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Sleep-Opt-In: A Randomized Controlled Pilot Study to Improve Sleep and Glycemic Variability in Adults With Type 1 Diabetes.
Martyn-Nemeth, P, Duffecy, J, Quinn, L, Steffen, A, Baron, K, Chapagai, S, Burke, L, Reutrakul, S
The science of diabetes self-management and care. 2023;49(1):11-22
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Insufficient sleep (insufficient total sleep time) and irregular sleep timing (variability in the occurrence of sleep within a 24-hour period) are increasingly recognized as important contributors to glycaemic control and variability in type 1 diabetes (T1D). The aims of this study were to evaluate the feasibility and acceptability of a sleep intervention (Sleep-Opt-In) targeted for adults with type 1 diabetes with short or irregular sleep and to examine the effects of Sleep-Opt-In on sleep duration and regularity, glucose indices, and patient-reported outcomes. This study was a randomised controlled parallel trial design. Participants (n=14) were randomly assigned to either the Sleep-Opt-In intervention or a Healthy Living attention control group. Results showed that: - Sleep-Opt-In was feasible and acceptable to the target population. - participants with objectively confirmed short or irregular sleep, sleep irregularity improved by 25 minutes on average, whereas sleep duration improved only negligibly (8 minutes). - the control group experienced an increase in sleep duration but no change in sleep regularity. Authors conclude that Sleep-Opt-In is feasible, acceptable, and promising for further evaluation to improve sleep duration or regularity, glucose parameters and important patient reported outcomes of diabetes distress, daytime sleepiness, fatigue and depressive mood in the T1D population.
Abstract
PURPOSE The purpose of this study was to evaluate the feasibility and acceptability of a technology-assisted behavioral sleep intervention (Sleep-Opt-In) and to examine the effects of Sleep-Opt-In on sleep duration and regularity, glucose indices, and patient-reported outcomes. Short sleep duration and irregular sleep schedules are associated with reduced glycemic control and greater glycemic variability. METHODS A randomized controlled parallel-arm pilot study was employed. Adults with type 1 diabetes (n = 14) were recruited from the Midwest and randomized 3:2 to the sleep-optimization (Sleep-Opt-In) or Healthy Living attention control group. Sleep-Opt-In was an 8-week, remotely delivered intervention consisting of digital lessons, sleep tracker, and weekly coaching phone calls by a trained sleep coach. Assessments of sleep (actigraphy), glucose (A1C, continuous glucose monitoring), and patient-reported outcomes (questionnaires for daytime sleepiness, fatigue, diabetes distress, and depressive mood) were completed at baseline and at completion of the intervention. RESULTS Sleep-Opt-In was feasible and acceptable. Those in Sleep-Opt-In with objectively confirmed short or irregular sleep demonstrated an improvement in sleep regularity (25 minutes), reduced glycemic variability (3.2%), and improved time in range (6.9%) compared to the Healthy Living attention control group. Patient-reported outcomes improved only for the Sleep-Opt-In group. Fatigue and depressive mood improved compared to the control. CONCLUSIONS Sleep-Opt-In is feasible, acceptable, and promising for further evaluation as a means to improve sleep duration or regularity in the population of people with type 1 diabetes.
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Late, but Not Early, Night Sleep Loss Compromises Neuroendocrine Appetite Regulation and the Desire for Food.
Meyhöfer, S, Chamorro, R, Hallschmid, M, Spyra, D, Klinsmann, N, Schultes, B, Lehnert, H, Meyhöfer, SM, Wilms, B
Nutrients. 2023;15(9)
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Sleep loss has become common in modern societies. In parallel, the prevalence of obesity and metabolic comorbidities, such as type 2 diabetes, are rising worldwide. The aim of this study was to investigate the impact of the specific timing of sleep loss compared to regular sleep on appetite regulation and desire for foods. This study was a randomised, balanced, crossover design on three conditions spaced at least three and at maximum five weeks apart. Fifteen healthy young male participants were included. All participants had a regular sleep–wake cycle during the last four weeks before the experiments, with a minimum of 7 hours sleep per night. Results showed that ‘late-night sleep loss’, but not ‘early-night sleep loss’, elevated ghrelin concentrations, as well as feelings of hunger and appetite, and desire for food during the subsequent morning. Leptin concentrations were not affected by acute sleep loss per se, nor timing of sleep loss. Authors conclude that their findings could be of clinical interest to healthcare practitioners working with sleep deprived individuals, regarding sleep hygiene and appropriate sleep recommendations.
Abstract
OBJECTIVE There is evidence that reduced sleep duration increases hunger, appetite, and food intake, leading to metabolic diseases, such as type 2 diabetes and obesity. However, the impact of sleep timing, irrespective of its duration and on the regulation of hunger and appetite, is less clear. We aimed to evaluate the impact of sleep loss during the late vs. early part of the night on the regulation of hunger, appetite, and desire for food. METHODS Fifteen normal-weight ([mean ± SEM] body-mass index: 23.3 ± 0.4 kg/m2) healthy men were studied in a randomized, balanced, crossover design, including two conditions of sleep loss, i.e., 4 h sleep during the first night-half ('late-night sleep loss'), 4 h sleep during the second night-half ('early-night sleep loss'), and a control condition with 8h sleep ('regular sleep'), respectively. Feelings of hunger and appetite were assessed through visual analogue scales, and plasma ghrelin and leptin were measured from blood samples taken before, during, and after night-time sleep. RESULTS Ghrelin and feelings of hunger and appetite, as well as the desire for food, were increased after 'late-night sleep loss', but not 'early-night sleep loss', whereas leptin remained unaffected by the timing of sleep loss. CONCLUSIONS Our data indicate that timing of sleep restriction modulates the effects of acute sleep loss on ghrelin and appetite regulation in healthy men. 'Late-night sleep loss' might be a risk factor for metabolic diseases, such as obesity and type 2 diabetes. Thereby, our findings highlight the metabolic relevance of chronobiological sleep timing.
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Effect of aerobic exercise, slow deep breathing and mindfulness meditation on cortisol and glucose levels in women with type 2 diabetes mellitus: a randomized controlled trial.
Obaya, HE, Abdeen, HA, Salem, AA, Shehata, MA, Aldhahi, MI, Muka, T, Marques-Sule, E, Taha, MM, Gaber, M, Atef, H
Frontiers in physiology. 2023;14:1186546
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Stress is considered to be an important factor in type 2 diabetes mellitus (T2DM) and aerobic exercise can help modulate the stress response as well as being important in the management of diabetes. Mindfulness meditation and deep breathing have also been shown to have positive effects on both stress and T2DM. This 6-week single-blind, randomised, controlled trial evaluated the effect of 10 min slow deep breathing and 10 min mindfulness meditation following a 40 min aerobic exercise programme, compared to the 40 min aerobic exercise alone, on fasting blood glucose (FBG) and cortisol levels in 58 stressed women with T2DM. FBG and cortisol levels improved in both groups but more so in the group who received the deep breathing and mindfulness meditation in addition to the exercise intervention: 20% vs 30% reduction in cortisol and 10% vs 15% reduction in FBG. The authors conclude that adding slow deep breathing and mindfulness meditation to an exercise programme may be useful in the management of stressed women with T2DM and reduce their cardiometabolic risk.
Expert Review
Conflicts of interest:
None
Take Home Message:
Practitioners could consider slow deep breathing and mindfulness meditation, added to aerobic exercise, as potentially useful components of the T2DM management program for stressed women.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
Stress, a key factor for Type 2 diabetes mellitus (T2DM), stimulates the hypothalamus-pituitary-adrenal gland (HPA) and triggers parasympathetic nerve withdrawal, leading to increased circulating cortisol levels and higher levels of blood glucose. Exercise is a key intervention that can modulate the HPA axis and help manage stress.
Methods
Fifty-eight women (aged between 40-50), diagnosed with T2DM for at least 5 years but medically stable with moderate to high stress scores were randomised to either aerobic training (AT) or aerobic exercise combined with slow deep breathing and mindfulness meditation (DMM) training three times weekly over 6-weeks.
AT group performed aerobic exercise on a treadmill at an intensity of 60%– 75% of the maximum heart rate for a total of 40 min, including a 5 minute warm up and 5 min cool down.
AT + DMM group performed a combination of aerobic exercise as per the AT group followed by a total of 10 minutes of diaphragmatic slow, deep breathing; and mindfulness meditation.
Results
Both groups showed a change from baseline in serum cortisol to p<0.0001
At 6 weeks in the AT + DMM group, the primary outcome of serum cortisol (nmol/L) levels was 12.59 nmol/L [95% CI 4.45-6.52] a decrease of 30.29% and the fasting blood glucose levels (secondary outcome) was 136.37mg/dl (95% CI: 9.19–2.6) a decrease of 14.54%
In the AT group performing only aerobic exercise decreased serum cortisol levels by 20.16% and FBG levels decreased by 9.97%.
Conclusion
This study showed that combining slow deep breathing and mindfulness meditation with aerobic exercise reduced the serum cortisol (p = 0.01) and FBG levels (p = 0.001) in women with T2DM compared to when only aerobic training was performed.
Clinical practice applications:
Consider a combined therapy approach with diaphragmatic breathing exercises and aerobic exercises that targets both the endocrine and autonomic nervous systems, as this may have a synergistic effect to assist with maintaining normal blood sugar levels and cortisol levels in individuals with T2DM.
Considerations for future research:
Future research is needed to determine the most effective combination of therapies for managing both FBG and serum cortisol levels in individuals with T2DM.
Abstract
Background: Aerobic exercise combined with breathing exercise can be an integral part of diabetes mellitus treatment. This single-center, randomized, parallel-group study investigated the effect of the combination of aerobic exercise with slow deep breathing and mindfulness meditation on the glucose and cortisol levels of women with type 2 diabetes mellitus (T2DM). Materials and Methods: Fifty-eight middle-aged women with T2DM (mean age: 45.67 ± 2.92 years) were randomly assigned to either the aerobic training group (AT: n = 29; mean age [46.1 ± 2.7 years]) or the aerobic exercise combined with slow deep breathing and mindfulness meditation (AT + DMM: n = 29; mean age [45.24 ± 3.14 years]). Aerobic exercise was performed at 60%-75% of the maximum heart rate. The women in each group were asked to perform the training three times weekly over a 6-week period. The duration of each session was 40 min for the AT group and 60 min for the AT + DMM group. The two groups were asked to perform aerobic exercise at 60%-75% of the maximum heart rate. Their fasting blood glucose (FBG) and serum cortisol levels were measured at the baseline and after the 6 weeks. Results: Compared with the AT group, the group undertaking 6 weeks of aerobic training combined with slow, deep breathing exercises and mindfulness meditation showed significantly lower levels of FBG (p = 0.001) and cortisol levels (p = 0.01) than the AT group. Conclusion: The addition of slow deep breathing and mindfulness meditation to aerobic exercise can better control the glucose and cortisol levels of women with T2DM and thereby improve their outcomes and decrease their cardiometabolic risk.
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Cognitive behavioral therapy for lifestyle changes in patients with obesity and type 2 diabetes: a systematic review and meta-analysis.
Kurnik Mesarič, K, Pajek, J, Logar Zakrajšek, B, Bogataj, Š, Kodrič, J
Scientific reports. 2023;13(1):12793
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Obesity and type 2 diabetes mellitus (T2DM) are two of the most common chronic diseases and lifestyle modification, including diet, exercise and weight management, are recognised as important for prevention. Cognitive behavioural therapy (CBT) has been shown to contribute to lifestyle modification. The aim of this meta-analysis was to evaluate the effect of CBT, compared to no intervention/standard care only, in patients with obesity and/or T2DM, with a focus on health outcomes and implementation of changes long-term. Nine randomised controlled trials (RCT) with 902 participants were included in this meta-analysis. The health outcomes included weight loss and maintenance and glycosylated haemoglobin (HbA1c, a measure of blood glucose control) whilst the lifestyle changes included diet, physical activity, smoking, and compliance with treatments. There was a statistically significant benefit of CBT for weight loss and weight maintenance (based on 3 RCTs each) with a medium effect size, but no significant effect on HbA1c (based on 3 RCTs). In all 3 RCTs that evaluated depression, a significant benefit was observed. As the behavioural outcomes were too heterogenous to be pooled for a meta-analysis, they were reviewed in a descriptive manner only. Benefits were reported in terms of better dietary choices/reduced energy intake, increased physical activity, better adherence to medication and glucose monitoring as well as a reduction in smoking. The authors suggest that CBT appears to be moderately effective in promoting lifestyle modifications and weight loss.
Abstract
The aim of this systematic review and meta-analysis was to examine the contribution of cognitive behavioral therapy (CBT) to the implementation of lifestyle changes, considering health-related and behavioral outcomes. A systematic literature review was performed using multiple databases (PsycInfo, PubMed and MEDLINE). The inclusion criteria comprised randomised controlled trials of CBT for lifestyle changes in patients with obesity and/or type 2 diabetes. The quality of study reporting was assessed with the revised Cochrane Collaboration's risk of bias tool. A meta-analysis was conducted on studies with appropriate outcomes. Nine randomised controlled trials, with a total sample size of 902 participants, met the inclusion criteria. The meta-analysis has shown a medium, significant effect size of CBT interventions for weight loss and weight maintenance, and a low, non-significant effect size of CBT interventions for reducing glycated hemoglobin (HbA1c) levels. A separate, combined, meta-analysis for all nine calculated effect sizes has yielded a medium and significant overall effect size for the model. Our review of the studies about the effectiveness of CBT in implementing lifestyle changes has, in comparison to usual control groups, proven the efficacy of CBT interventions in implementing lifestyle changes, especially for weight loss and weight maintenance.
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The effect of synbiotic supplementation on hypothyroidism: A randomized double-blind placebo controlled clinical trial.
Ramezani, M, Reisian, M, Sajadi Hezaveh, Z
PloS one. 2023;18(2):e0277213
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Despite the increased awareness and the improvements in medical management of hypothyroidism; depression, mood disturbance and poor health-related quality of life (QoL) is common among hypothyroid patients. Synbiotics have been advocated as being beneficial to patients with metabolic diseases. Synbiotics are a mixture of probiotics and prebiotics that beneficially affect the host by improving the survival and stimulating the growth of advantageous and health promoting microbial species in the gastrointestinal tract. The aim of this study was to examine whether synbiotic supplementation could enhance depression, QoL, and blood pressure, as well as thyroid hormones in hypothyroid patients. This study is a 10-week parallel design randomised placebo-controlled trial. Participants – adults with hypothyroidism - were randomly assigned to the synbiotic (n = 28) or the placebo (n = 28) group. Results show that following 10 weeks supplementation with synbiotics (500 mg of 10⁹ CFU/g probiotics plus fructo-oligosaccharide) in comparison to placebo does not affect serum thyroid stimulating hormone level and depression. However, it significantly improved blood pressure levels and various domains and areas of QoL. Authors conclude that further clinical trials are needed to assess the effectiveness of a synbiotic supplementation along with the current routine treatment for hypothyroid patients.
Abstract
OBJECTIVE We hypothesize that synbiotic supplementation could modulate the intestinal microbiota and subsequently, improve the condition of hypothyroid patients. METHODS Fifty-six adult hypothyroid patients were recruited to this double-blind, placebo-controlled, randomized clinical trial. The intervention was 10 weeks of synbiotic (500 mg of 109 CFU/g probiotics plus fructo-oligosaccharide, n = 28) compared to placebo (lactose, magnesium stearate, talc, and silicon dioxide, n = 28). Randomization and allocation to trial groups were carried out using random number sequences drawn from https://sealedenvelope.com/. Primary outcomes were serum thyroid stimulating hormone (TSH) and free thyroxine (FT4), and secondary outcomes were depression, quality of life, and blood pressure (BP). P-values< 0.05 were considered statistically significant. RESULTS Analysis on 51 patients who completed the trial showed that TSH and depression (p> 0.05) did not change significantly, while serum FT4 significantly increased in both groups (p = 0.03 and p = 0.02 in symbiotic and placebo respectively). A significant decrease in systolic BP occurred only in the synbiotic group (p = 0.05). Significant improvements occurred regarding different domains and areas of quality of life in the crude and adjusted analysis, including perceived mental health (p = 0.02), bodily pain (p = 0.02), general health perception (p = 0.002), and wellbeing (p = 0.002), which were significantly higher in the synbiotic group. CONCLUSIONS Ten-week supplementation with synbiotic had no favorable effect on depression and TSH, but it improved blood pressure and quality of life in patients with hypothyroidism. More trials are needed to support or reject these findings. TRIAL REGISTRATION IRCT20210926052583N1, Iranian Registry of Clinical Trials (IRCT), registered October 1st, 2021.
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Effects of acute sleep loss on leptin, ghrelin, and adiponectin in adults with healthy weight and obesity: A laboratory study.
van Egmond, LT, Meth, EMS, Engström, J, Ilemosoglou, M, Keller, JA, Vogel, H, Benedict, C
Obesity (Silver Spring, Md.). 2023;31(3):635-641
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A lack of sleep may be a risk factor for weight gain. Leptin is an adipocyte-derived hormone that activates satiety networks within the brain. Ghrelin, as opposed to leptin, is mainly produced by the stomach and it acts as a hunger hormone, signalling fuel status to the central nervous system. Some studies have found either no alterations or higher leptin and lower ghrelin blood levels following experimental sleep deprivation. The aim of this study was to investigate whether blood concentrations of leptin, ghrelin, and adiponectin are affected by acute total sleep deprivation in a sex- and weight-specific manner. This study is a laboratory study based on blood samples from 44 participants, mainly university students. Results show that: - acute total sleep deprivation is linked to lower serum levels of the adipokine leptin and higher blood levels of ghrelin. - following sleep deprivation, serum adiponectin levels were elevated. - the drop in serum leptin was larger in women after total sleep deprivation; however, there wasn’t a significant association between biological sex and experimental condition. - the increase in blood levels of adiponectin was slightly more pronounced among women, whereas there weren’t any differences in the effects of sleep loss on plasma ghrelin. Authors conclude that acute total sleep deprivation shifts the endocrine balance from the satiety hormone leptin toward the hunger-promoting hormone ghrelin. However, further investigation in larger samples focusing on their findings linked to sex- and weight-specific differences in leptin, ghrelin, and adiponectin are needed.
Expert Review
Conflicts of interest:
None
Take Home Message:
Sleep deprivation may shift the balance of appetite controlling hormones causing an increase in hunger and decreased satiety and therefore resulting in increased food intake. These changes may be more pronounced in biological females.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
Sleep deprivation may contribute to weight gain and obesity through its effect on the hormonal pathways promoting hunger and satiety. Research has also linked chronic sleep loss with an increase in the brain reward response to food, thus driving an increase in daily food intake. Leptin and ghrelin are hormones involved in the control of food intake. Some research has associated alterations in these hormones following sleep loss, whilst others have not.
This study aimed to investigate whether biological sex and weight status affect fasting serum levels of leptin, ghrelin and adiponectin following chronic sleep deprivation in a supervised laboratory setting.
Methods
This randomised crossover design study included n=44 mixed sex participants with a mean age of 24.9 years. A total of 19 of the participants were classed as obese, with the remaining n= 25 participants were considered normal weight. Participants completed 2 nights in experimental sessions under continuously supervised conditions in a laboratory. One night was spent awake and the other asleep. Fasting blood samples were taken the morning after each session to measure levels of leptin, ghrelin and adiponectin.
Results
Serum levels of leptin after one night’s sleep loss were around 7% lower than those measured after sleep (17.3 = +/-2.6 vs 18.6 +/- 2.8 ng/mL, p = 0.037). Adjustments using sex-stratified analysis showed significantly lower levels of serum leptin in women (25.8 +/_4.3 vs 28.1 +/_ 4.7 ng/mL, p = 0.030) but not for men (10.1 +/_ 2.4 vs 10.6 +/_ 2.3 ng/mL, p = 0.458). However, when comparing individual participant differences between sleep and wake sessions, the results were not significant. Additionally, no significant differences were found between normal weight and obese participants.
Higher levels of ghrelin were found following sleep deprivation in both sexes and weight sub-groups (839.4 +/-77.5 vs 741.4+/-63.2 pg/mL, p= 0.003). Adiponectin was also found to be elevated in all participants regardless of biological sex or weight status (7.5 +/- 0.6 vs 6.8 +/- 0.6ug/mL, p= 0.003). However, ghrelin was observed to increase slightly more in participants with obesity, whereas elevations in adiponectin were slightly greater in those of normal weight.
Conclusion
In this study, sleep loss was associated with lowered levels of leptin and higher levels of ghrelin. Analysis between biological sexes indicated that there may be a greater decrease in leptin in females. Serum levels of adiponectin were also found to be elevated after sleep deprivation for both sexes with a slightly larger increase in women. These changes may result in increased hunger and food intake and decreased satiety. No significant differences were found between normal weight and obese participants.
Notes: The authors reported no conflicts of interest.
Clinical practice applications:
Sleep deprivation may lead to lower levels of leptin in both sexes with a greater decrease for females. Ghrelin and adiponectin levels may be increased in both men and women after sleep loss with a slightly larger increase in adiponectin for women. This could lead to an increase in appetite, food consumption and therefore weight gain, particularly in women.
Considerations for future research:
- Larger studies are needed to investigate sex and weight status related differences in serum levels of ghrelin, leptin and adiponectin.
- It may be beneficial for blood samples to be taken at different points during the day to allow for fluctuations in hormone levels.
- Food intake should be measured to monitor any increases in food intake.
Abstract
OBJECTIVE This study investigated whether blood concentrations of leptin, ghrelin, and adiponectin are affected by acute total sleep deprivation in a sex- and weight-specific manner. METHODS A total of 44 participants (mean age 24.9 years; 20 women; 19 with obesity) participated in a crossover design, including one night of sleep deprivation and one night of sleep in the laboratory. After each night, fasting blood was collected. RESULTS After sleep deprivation, fasting levels of leptin were lower (mean [SE], vs. sleep: 17.3 [2.6] vs. 18.6 [2.8] ng/mL), whereas those of ghrelin and adiponectin were higher (839.4 [77.5] vs. 741.4 [63.2] pg/mL and 7.5 [0.6] vs. 6.8 [0.6] μg/mL, respectively; all p < 0.05). The changes in leptin and adiponectin following sleep loss were more pronounced among women. Furthermore, the ghrelin increase was stronger among those with obesity after sleep loss. Finally, the sleep loss-induced increase in adiponectin was more marked among normal-weight participants. CONCLUSIONS Acute sleep deprivation reduces blood concentrations of the satiety hormone leptin. With increased blood concentrations of ghrelin and adiponectin, such endocrine changes may facilitate weight gain if persisting over extended periods of sleep loss. The observed sex- and weight-specific differences in leptin, ghrelin, and adiponectin call for further investigation.
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Effectiveness of Therapeutic Patient Education Interventions in Obesity and Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Correia, JC, Waqas, A, Huat, TS, Gariani, K, Jornayvaz, FR, Golay, A, Pataky, Z
Nutrients. 2022;14(18)
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Obesity and diabetes mellitus (DM) account for the highest burden of non-communicable diseases. Obesity is also highly comorbid with type 2 DM with a prevalence of 8.5% among adults around the globe. The aims of this study were to present (a) a critical synthesis of the theoretical basis and development of therapeutic patient education (TPE) interventions for obesity and diabetes, and (b) quantitative evidence for the efficacy of these interventions across a range of biomedical, psychosocial and psychological outcomes. This study is a systematic review and meta-analysis of fifty-four randomised controlled trials. Results show that: - TPE interventions bring about significant improvements in biomedical outcomes among patients with DM and obesity. - there weren’t significant differences in the quality of life of participants undergoing TPE interventions (inconclusive as only data from two studies were considered). - interventions delivered through different media and delivery formats may be equally effective. Authors conclude that the use of electronic media such as short messaging services, website-based educational programs and animation media can be used to deliver TPE effectively.
Abstract
Diabetes mellitus (DM) and obesity account for the highest burden of non-communicable diseases. There is increasing evidence showing therapeutic patient education (TPE) as a clinically and cost-effective solution to improve biomedical and psychosocial outcomes among people with DM and obesity. The present systematic review and meta-analysis present a critical synthesis of the development of TPE interventions for DM and obesity and the efficacy of these interventions across a range of biomedical, psychosocial and psychological outcomes. A total of 54 of these RCTs were identified among patients with obesity and diabetes and were thus qualitatively synthesized. Out of these, 47 were included in the quantitative synthesis. There was substantial heterogeneity in the reporting of these outcomes (I2 = 88.35%, Q = 317.64), with a significant improvement noted in serum HbA1c levels (standardized mean difference (SMD) = 0.272, 95% CI: 0.118 to 0.525, n = 7360) and body weight (SMD = 0.526, 95% CI: 0.205 to 0.846, n = 1082) in the intervention group. The effect sizes were comparable across interventions delivered by different modes and delivery agents. These interventions can be delivered by allied health staff, doctors or electronically as self-help programs, with similar effectiveness (p < 0.001). These interventions should be implemented in healthcare and community settings to improve the health outcomes in patients suffering from obesity and DM.
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The relationship between diabetes mellitus and attention deficit hyperactivity disorder: A systematic review and meta-analysis.
Ai, Y, Zhao, J, Liu, H, Li, J, Zhu, T
Frontiers in pediatrics. 2022;10:936813
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Attention deficit hyperactivity disorder (ADHD) is the most common neurodevelopmental disorder characterised by inattention and/or hyperactivity/impulsivity. Several studies have found bidirectional associations between ADHD and diabetes mellitus (DM). The aims of this study were to assess the prevalence of ADHD in DM patients as well as the prevalence of DM in ADHD patients compared with those without ADHD, and to explore the impacts of ADHD on glycaemic control in patients with DM. This study is a systematic review and meta-analysis of 17 articles; five were cohort studies, three were case-control studies, and nine were cross-sectional studies. Results through the pooled analyses suggest an important comorbid relationship between diabetes and ADHD. Overall, there was an increase in T2DM of 166% and 51% in children and adults with ADHD, respectively, relative to those without ADHD. Furthermore, there was an overall 37% increase in T1DM in children with ADHD. Authors conclude that further studies are needed to better understand the relationship between ADHD and DM. Additionally, it is important to take into consideration the type of DM if this association is different in various age groups (children and adults).
Abstract
BACKGROUND This study aims to investigate the prevalence estimate of diabetes mellitus (DM) among people with attention deficit hyperactivity disorder (ADHD) as well as the prevalence of ADHD among those with DM. In addition, the impact of ADHD on glycemic control in patients with DM was also assessed using a systematic review and meta-analysis of currently available published data. MATERIALS AND METHODS The PubMed, Embase, Web of Science, and PsycInfo databases were searched for potential studies. Two reviewers independently selected studies according to the inclusion and exclusion criteria. All pooled analyses were conducted using the random-effects models on Review Manager 5.3. RESULTS Seventeen observational studies were included. The pooled results showed an increase in the prevalence of DM among patients with ADHD versus those without ADHD [type 1 DM OR 1.37 (95% CI: 1.17-1.61); type 2 DM OR 2.05 (95% CI: 1.37-3.07)]. There was an overall 35% increase in the prevalence of ADHD among patients with type 1 DM [OR: 1.35 (95% CI: 1.08-1.73)]. Children with type 1 DM and ADHD had higher levels of hemoglobin A1c [standardized mean of differences: 0.67 (95% CI: 0.48-0.86)], and prevalence of hypoglycemic and ketoacidosis index compared with those without ADHD. CONCLUSION Our study revealed the bidirectional associations between ADHD and DM. Patients with ADHD and type 1 DM comorbidities were more likely to have poorer diabetes control. More studies are needed to confirm this association and elucidate the underlying mechanism.
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Enhancing Night and Day Circadian Contrast through Sleep Education in Prediabetes and Type 2 Diabetes Mellitus: A Randomized Controlled Trial.
García-Serrano, C, Pujol Salud, J, Aran-Solé, L, Sol, J, Ortiz-Congost, S, Artigues-Barberà, E, Ortega-Bravo, M
Biology. 2022;11(6)
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Diabetes mellitus is a chronic condition that occurs when blood glucose levels increase because the body cannot produce enough insulin or cannot effectively use the insulin it produces. Type 2 diabetes mellitus (T2DM) is the most common type of diabetes. It is a chronic metabolic disease that can be controlled when its pathophysiological factors are neutralised. The aim of this study was to analyse the effect of a sleep hygiene intervention in the management of impaired fasting glucose (IFG) and T2DM. This is an experimental study based on a parallel clinical trial using blocked randomization with equal allocation ratio. A total of 69 participants were included in the analysis (31 and 38 from the control and intervention groups, respectively). Results show a significant improvement in all the measured sleep parameters (sleep quality, time and efficiency). Furthermore, it also demonstrates that sleep health educational intervention, delivered during the regular check-ups of patients with T2DM or IFG, has a positive metabolic effect and is feasible as a complementary therapy in primary care settings. Authors conclude that sleep education improves T2DM metabolic management.
Expert Review
Conflicts of interest:
None
Take Home Message:
- Sleep has a restorative function that benefits glucose metabolism.
- Sleep education should emphasise that maintaining a regular and sufficient sleep schedule and establishing a series of routines and habits in the hours prior to going to sleep would prevent early awakenings.
- Education is an important part of clinical practice.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
The aim of this study was to analyse the effect of a sleep hygiene intervention in the management of impaired fasting glucose (IFG) or type 2 diabetes mellitus (T2DM).
Methods
This experimental parallel open-label clinical trial included 69 adults with IFG or T2DM.
The intervention was individual informative education which aimed to develop skills to improve sleep, which consisted of:
1. Information: Reading of the educational sheet (9 tips for a healthy sleep) with subsequent discussion.
2. Verification: checking participants understood the advice.
3. Participant information: One telephone call after 1 month was made as educational reinforcement of the intervention.
The controlled group received no educational intervention. The main outcome variable measured was levels of HbA1c (%) 3 and 6 months post intervention. Secondary outcomes were fasting glucose (mg/dL) 3 and 6 months post intervention, Pittsburgh Sleep Quality Index (PSQI), declared sleep hours and sleeping efficiency 3 months post intervention.
Results
- . 84.2% participants from the intervention group and 14.0% in the control group reported a change in sleep habits.
- 3 months after the intervention, the control group did not report any change, while the intervention group reported a statistically significant improvement in all three: PSQI (−2.97 ± 2.93), hours of sleep (1.00 [0.00; 2.00] hours) and sleep efficiency (6.74 ± 12.9%).
- The intervention group achieved a significant reduction in 3 months post intervention fasting glucose levels (−14.69; CI 95%: −28.15, −1.22) and HbA1c levels (−0.39; 95% CI: −0.73, −0.05), as well as a reduction in 6 months post intervention HbA1c levels (−0.66; 95% CI: −0.96, −0.36).
Conclusion
- The results show a significant improvement in all the measured sleep parameters (sleep quality, time and efficiency).
- The PSQI score improvement in the intervention group was 3.6 points higher than the control group.
- The median sleep time in the intervention group was increased by 1.5 h, doubling the number of participants who reported sleeping more than 6 h.
Clinical practice applications:
- An educational intervention in sleep hygiene and circadian contrast may help to increase sleep quality, time and efficiency.
- The educational intervention helped lower HbA1c levels in patients with IFG and T2DM.
- Sleep education helps to improve T2DM metabolic management.
- The 9 tips for a healthy sleep, were developed from the latest guidelines from the American Academy of Sleep Medicine, the National Health Service, and the Health Department of Catalonia.
Considerations for future research:
- The open-labelled intervention and the use of subjective variables related to sleep quality could lead to biassed self-reports in the intervention group so further studies are required.
- Future studies should gather baseline parameters closer to the start of the intervention rather than wait 3 months to assess the immediate outcomes of the intervention.
- Future research could take the same approach with diet and exercise education.
Abstract
BACKGROUND Evidence supports a causal relationship between circadian disturbance and impaired glucose homeostasis. METHODS To determine the effect of an educational intervention delivered by primary care nurses to improve sleep hygiene, a parallel, open-label clinical trial in subjects aged 18 and older with impaired fasting glucose (IFG) or type 2 diabetes mellitus (T2DM) was performed. Study variables were sex, age, fasting glucose, glycated haemoglobin A1c (HbA1c), Pittsburgh Sleep Quality Index (PSQI), sleep duration and efficiency, body mass index, antidiabetic treatment, diet and physical exercise. An individual informative educational intervention was carried out following a bidirectional feedback method. The intervention aimed to develop skills to improve sleep through nine simple tips. An analysis of covariance was performed on all the mean centred outcome variables controlling for the respective baseline scores. RESULTS In the intervention group, PSQI dropped, the duration and quality of sleep increased, and a decrease in fasting glucose and in HbA1c levels was observed. CONCLUSION The proposed intervention is effective for improving sleep quality, length and efficiency, and for decreasing fasting glucose and HbA1c levels in only 3 months. These findings support the importance of sleep and circadian rhythm education focused on improving IFG and T2DM.
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10.
Cardiometabolic Risk Factors and Incident Cardiovascular Disease Events in Women vs Men With Type 1 Diabetes.
Braffett, BH, Bebu, I, El Ghormli, L, Cowie, CC, Sivitz, WI, Pop-Busui, R, Larkin, ME, Gubitosi-Klug, RA, Nathan, DM, Lachin, JM, et al
JAMA network open. 2022;5(9):e2230710
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Plain language summary
In the general population, women have a lower absolute risk of cardiovascular disease (CVD) compared with men. However, among individuals with type 1 or type 2 diabetes, the relative risk of CVD is similar or higher in women compared with men. The aim of this study was to assess sex differences in achieving recommended CVD risk management targets and associations with CVD events. This is a cohort study which included a total of 1441 (men n= 736) participants with type 1 diabetes. Results show that the prevalence and mean levels of most cardiometabolic risk factors (except for pulse rate and haemoglobin A1c) were consistent with a less atherogenic profile among women compared with men. Furthermore, achieving treatment targets for blood pressure, lipids, and glucose was associated with significantly decreased risk of CVD in both women and men. Authors conclude that their findings argue for a recalibration of CVD risk factor stratification in revised clinical care guidelines and therapeutic recommendations by sex for individuals with type 1 diabetes.
Abstract
IMPORTANCE The lower risk of cardiovascular disease (CVD) among women compared with men in the general population may be diminished among those with diabetes. OBJECTIVE To evaluate cardiometabolic risk factors and their management in association with CVD events in women vs men with type 1 diabetes enrolled in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. DESIGN, SETTING, AND PARTICIPANTS This cohort study used data obtained during the combined DCCT (randomized clinical trial, conducted 1983-1993) and EDIC (observational study, conducted 1994 to present) studies through April 30, 2018 (mean [SD] follow-up, 28.8 [5.8] years), at 27 clinical centers in the US and Canada. Data analyses were performed between July 2021 and April 2022. EXPOSURE During the DCCT phase, patients were randomized to intensive vs conventional diabetes therapy. MAIN OUTCOMES AND MEASURES Cardiometabolic risk factors and CVD events were assessed via detailed medical history and focused physical examinations. Blood and urine samples were assayed centrally. CVD events were adjudicated by a review committee. Linear mixed models and Cox proportional hazards models evaluated sex differences in cardiometabolic risk factors and CVD risk over follow-up. RESULTS A total of 1441 participants with type 1 diabetes (mean [SD] age at DCCT baseline, 26.8 [7.1] years; 761 [52.8%] men; 1390 [96.5%] non-Hispanic White) were included. Over the duration of the study, compared with men, women had significantly lower body mass index (BMI, calculated as weight in kilograms divided by height in meters squared; β = -0.43 [SE, 0.16]; P = .006), waist circumference (β = -10.56 cm [SE, 0.52 cm]; P < .001), blood pressure (systolic: β = -5.77 mm Hg [SE, 0.35 mm Hg]; P < .001; diastolic: β = -3.23 mm Hg [SE, 0.26 mm Hg]; P < .001), and triglyceride levels (β = -10.10 mg/dL [SE, 1.98 mg/dL]; P < .001); higher HDL cholesterol levels (β = 9.36 mg/dL [SE, 0.57 mg/dL]; P < .001); and similar LDL cholesterol levels (β = -0.76 mg/dL [SE, 1.22 mg/dL]; P = .53). Women, compared with men, achieved recommended targets more frequently for blood pressure (ie, <130/80 mm Hg: 90.0% vs 77.4%; P < .001) and triglycerides (ie, <150 mg/dL: 97.3% vs 90.5%; P < .001). However, sex-specific HDL cholesterol targets (ie, ≥50 mg/dL for women, ≥40 mg/dL for men) were achieved less often (74.3% vs 86.6%; P < .001) and cardioprotective medications were used less frequently in women than men (ie, angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker: 29.6% [95% CI, 25.7%-33.9%] vs 40.0% [95% CI, 36.1%-44.0%]; P = .001; lipid-lowering medication: 25.3% [95% CI, 22.1%-28.7%] vs 39.6% [95% CI, 36.1%-43.2%]; P < .001). Women also had significantly higher pulse rates (mean [SD], 75.2 [6.8] beats per minute vs 71.8 [6.9] beats per minute; P < .001) and hemoglobin A1c levels (mean [SD], 8.3% [1.0%] vs 8.1% [1.0%]; P = .01) and achieved targets for tighter glycemic control less often than men (ie, hemoglobin A1c <7%: 11.2% [95% CI, 9.3%-13.3%] vs 14.0% [95% CI, 12.0%-16.3%]; P = .03). CONCLUSIONS AND RELEVANCE These findings suggest that despite a more favorable cardiometabolic risk factor profile, women with type 1 diabetes did not have a significantly lower CVD event burden than men, suggesting a greater clinical impact of cardiometabolic risk factors in women vs men with diabetes. These findings call for conscientious optimization of the control of CVD risk factors in women with type 1 diabetes.