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A nutritional biomarker score of the Mediterranean diet and incident type 2 diabetes: Integrated analysis of data from the MedLey randomised controlled trial and the EPIC-InterAct case-cohort study.
Sobiecki, JG, Imamura, F, Davis, CR, Sharp, SJ, Koulman, A, Hodgson, JM, Guevara, M, Schulze, MB, Zheng, JS, Agnoli, C, et al
PLoS medicine. 2023;20(4):e1004221
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Self-reported adherence to the Mediterranean diet (MedDiet) has been associated with a lower incidence of type 2 diabetes (T2D). However, as no biological indicators of whether people are really following the MedDiet have been recorded, it is difficult to definitively ascertain any associations. This post-hoc analysis of a randomised control trial and a cohort study aimed to determine indicative nutritional biomarkers associated with the MedDiet and to see if associations exist with the incidence of T2D. The study formulated a biomarker score based on 29 different nutrients that are in abundance in the MedDiet. This score was then applied to an observational study and showed that as the score went up and therefore adherence to the diet, the incidence of T2D went down and vice versa. Higher adherence to the MedDiet resulted in an 11% decrease in the incidence of T2D. It was concluded that adherence to the MedDiet may help to prevent T2D. This study could be used by healthcare professionals to recommend the commencement of the MedDiet in individuals who are risk of its development.
Abstract
BACKGROUND Self-reported adherence to the Mediterranean diet has been modestly inversely associated with incidence of type 2 diabetes (T2D) in cohort studies. There is uncertainty about the validity and magnitude of this association due to subjective reporting of diet. The association has not been evaluated using an objectively measured biomarker of the Mediterranean diet. METHODS AND FINDINGS We derived a biomarker score based on 5 circulating carotenoids and 24 fatty acids that discriminated between the Mediterranean or habitual diet arms of a parallel design, 6-month partial-feeding randomised controlled trial (RCT) conducted between 2013 and 2014, the MedLey trial (128 participants out of 166 randomised). We applied this biomarker score in an observational study, the European Prospective Investigation into Cancer and Nutrition (EPIC)-InterAct case-cohort study, to assess the association of the score with T2D incidence over an average of 9.7 years of follow-up since the baseline (1991 to 1998). We included 22,202 participants, of whom 9,453 were T2D cases, with relevant biomarkers from an original case-cohort of 27,779 participants sampled from a cohort of 340,234 people. As a secondary measure of the Mediterranean diet, we used a score estimated from dietary-self report. Within the trial, the biomarker score discriminated well between the 2 arms; the cross-validated C-statistic was 0.88 (95% confidence interval (CI) 0.82 to 0.94). The score was inversely associated with incident T2D in EPIC-InterAct: the hazard ratio (HR) per standard deviation of the score was 0.71 (95% CI: 0.65 to 0.77) following adjustment for sociodemographic, lifestyle and medical factors, and adiposity. In comparison, the HR per standard deviation of the self-reported Mediterranean diet was 0.90 (95% CI: 0.86 to 0.95). Assuming the score was causally associated with T2D, higher adherence to the Mediterranean diet in Western European adults by 10 percentiles of the score was estimated to reduce the incidence of T2D by 11% (95% CI: 7% to 14%). The study limitations included potential measurement error in nutritional biomarkers, unclear specificity of the biomarker score to the Mediterranean diet, and possible residual confounding. CONCLUSIONS These findings suggest that objectively assessed adherence to the Mediterranean diet is associated with lower risk of T2D and that even modestly higher adherence may have the potential to reduce the population burden of T2D meaningfully. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000602729 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363860.
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A Low-Carbohydrate Diet Realizes Medication Withdrawal: A Possible Opportunity for Effective Glycemic Control.
Han, Y, Cheng, B, Guo, Y, Wang, Q, Yang, N, Lin, P
Frontiers in endocrinology. 2021;12:779636
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Many studies have shown that diet restrictions can help glycemic control and reduce metabolic risks in patients with type 2 diabetes mellitus (T2DM). The aim of this study was to look at the efficacy of two diets, the LCD and the low-fat diet (LFD), on glycemic control and clinical treatment. The study was a prospective, open-label, double-arm, randomized controlled trial conducted from March 2019 to December 2020 in China. 134 T2DM participants took part and they were randomly assigned to the LCD group or the low -fat diet (LFD) group. The following were measured at the beginning and end of each intervention: weight, fasting blood glucose (FBG), postprandial 2-h blood glucose (PPG), glycosylated haemoglobin (HbA1c), antiglycemic medications, and medications for other diseases and emerging diseases. The effect of decreasing blood glucose control with the LCD is superior to that of the LFD for Chinese patients with T2DM. It also led to a lower medication effects score (MES). It can reduce body weight, BMI, and lipid-lowering agents. Strict diet control and monitoring are the keys to managing diabetes. Further larger scale studies are needed to obtain more evidence.
Abstract
Objective: Multiple studies have confirmed that diet restrictions can effectively realize glycemic control and reduce metabolic risks in patients with type 2 diabetes mellitus (T2DM). In 2018, the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) stated that individuals can select a low-carbohydrate diet (LCD) according to their needs and preferences. Owing to the influence of Chinese traditional eating habits, only a small portion of patients in China have achieved their blood glucose goals. As a result, the Chinese government will incur huge expenditures. Method: This study recruited 134 T2DM participants and randomly assigned them to the LCD group (n = 67) or the low-fat diet (LFD) group (n = 67). All of the patients had a fixed amount of exercise and were guided by clinicians. After a period of dietary washout, all of the patients received corresponding dietary education according to group. The follow-up time was 6 months. The indicators for anthropometry, glycemic control, and medication application parameters were collected and compared between the two groups. Results: There were 121 participants who finally entered the study. The proportions of calories from three major nutrients the participants consumed met the requirements of LCD and LFD. Compared with baseline, the pre-postdifferences of body weight, BMI, and several other indicators were significant except for dosages of insulin used in the LCD group and MES in the LFD group. After the intervention, body weight, body weight index (BMI), fasting blood glucose (FBG), postprandial 2-h blood glucose (PPG), and glycosylated hemoglobin (HbA1c) levels in the LCD group decreased significantly (p < 0.05) compared with the LFD group. The number of patients using lipid-lowering agents was significant higher in the LCD group and lower in the LFD group. However, there was no significant difference between the two groups for antihypertensive, hormone-replacement, and other agents. Conclusions: The LCD diet can decrease body weight, glycemic levels, MES, and lipid-lowering agents more than the LFD diet, thus decreasing cost burden in Chinese patients with T2DM. Strict diet control and monitoring are the keys to managing diabetes.
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The PREVIEW intervention study: Results from a 3-year randomized 2 x 2 factorial multinational trial investigating the role of protein, glycaemic index and physical activity for prevention of type 2 diabetes.
Raben, A, Vestentoft, PS, Brand-Miller, J, Jalo, E, Drummen, M, Simpson, L, Martinez, JA, Handjieva-Darlenska, T, Stratton, G, Huttunen-Lenz, M, et al
Diabetes, obesity & metabolism. 2021;23(2):324-337
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The main risk for the development of type 2 diabetes is being overweight or obese. Strategies to decrease weight are important to prevent its development or reverse disease. This long-term, randomised control trial of 2326 adults with prediabetes, aimed to compare the effectiveness of different maintenance diets, after initial weight loss; one which was high protein and low glycaemic index, and the other which was moderate protein and moderate glycaemic index. These diets were then combined with either moderate intensity or high intensity exercise. The results showed that after 3 years, the incidence of type 2 diabetes was low and did not differ between the diet and exercise groups. However, more individuals achieved normal blood sugar levels when on a moderate protein diet combined with moderate exercise and when on a high protein diet combined with moderate exercise. The high protein diet with high intensity exercise was the least effective at maintaining normal blood sugar levels. The amount of weight lost was the same no matter what combination of diet and exercise. It was concluded that the incidence of type 2 diabetes was lower than expected with the diet and exercise regimes and did not differ between the diets. This study could be used by healthcare professionals to introduce a long-term protocol combining weight loss, healthy eating, and physical activity to pre diabetic individuals who want to reduce their chance of developing type 2 diabetes.
Abstract
AIM: To compare the impact of two long-term weight-maintenance diets, a high protein (HP) and low glycaemic index (GI) diet versus a moderate protein (MP) and moderate GI diet, combined with either high intensity (HI) or moderate intensity physical activity (PA), on the incidence of type 2 diabetes (T2D) after rapid weight loss. MATERIALS AND METHODS A 3-year multicentre randomized trial in eight countries using a 2 x 2 diet-by-PA factorial design was conducted. Eight-week weight reduction was followed by a 3-year randomized weight-maintenance phase. In total, 2326 adults (age 25-70 years, body mass index ≥ 25 kg/m2 ) with prediabetes were enrolled. The primary endpoint was 3-year incidence of T2D analysed by diet treatment. Secondary outcomes included glucose, insulin, HbA1c and body weight. RESULTS The total number of T2D cases was 62 and the cumulative incidence rate was 3.1%, with no significant differences between the two diets, PA or their combination. T2D incidence was similar across intervention centres, irrespective of attrition. Significantly fewer participants achieved normoglycaemia in the HP compared with the MP group (P < .0001). At 3 years, normoglycaemia was lowest in HP-HI (11.9%) compared with the other three groups (20.0%-21.0%, P < .05). There were no group differences in body weight change (-11% after 8-week weight reduction; -5% after 3-year weight maintenance) or in other secondary outcomes. CONCLUSIONS Three-year incidence of T2D was much lower than predicted and did not differ between diets, PA or their combination. Maintaining the target intakes of protein and GI over 3 years was difficult, but the overall protocol combining weight loss, healthy eating and PA was successful in markedly reducing the risk of T2D. This is an important clinically relevant outcome.
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A Vegan Diet Is Associated with a Significant Reduction in Dietary Acid Load: Post Hoc Analysis of a Randomized Controlled Trial in Healthy Individuals.
Müller, A, Zimmermann-Klemd, AM, Lederer, AK, Hannibal, L, Kowarschik, S, Huber, R, Storz, MA
International journal of environmental research and public health. 2021;18(19)
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Diets high in meat and cheese, which are acidogenic and low in fruits and vegetables, which are alkalising, increase the dietary acid load (DAL) of the diet. Diets with a high DAL have been associated with poor health outcomes and the development of heart disease and type 2 diabetes. Plant-based diets have been associated with a lower DAL, however very little research exists on this. Individuals following a vegan diet have been shown in previous studies to have a reduced DAL, however it is unclear whether this was due to a reduced calorie intake or because of the diet composition. This post-hoc study aimed to investigate this and determine whether eating a vegan diet for 4-weeks reduced DAL and how this compares to 4-weeks of a diet rich in meat. The results showed that after 3-weeks, the vegan diet significantly reduced the DAL compared to the meat-rich diet, which increased the DAL. Interestingly all the participants in this study were put on the same balanced diet for 7 days prior to commencing the trial, reducing the chance that results would be affected by a prior diet. It was concluded that a vegan diet as opposed to a meat-rich diet may be of benefit to health outcomes through lowering DAL. This study could be used by healthcare professionals to understand that a balanced vegan diet may be of benefit to those who have heart disease and/or type 2 diabetes. However as this trial did not measure indicators of type 2 diabetes or heart disease, these associations are speculative.
Abstract
The composition of diet strongly affects acid-base homeostasis. Western diets abundant in acidogenic foods (meat and cheese) and deficient in alkalizing foods (fruits and vegetables) increase dietary acid load (DAL). A high DAL has been associated with numerous health repercussions, including cardiovascular disease and type-2-diabetes. Plant-based diets have been associated with a lower DAL; however, the number of trials exploring this association is limited. This randomized-controlled trial sought to examine whether an isocaloric vegan diet lowers DAL as compared to a meat-rich diet. Forty-five omnivorous individuals were randomly assigned to a vegan diet (n = 23) or a meat-rich diet (n = 22) for 4 weeks. DAL was determined using potential renal acid load (PRAL) and net endogenous acid production (NEAP) scores at baseline and after 3 and 4 weeks, respectively. After 3 weeks, median PRAL (-23.57 (23.87)) and mean NEAPR (12.85 ± 19.71) scores were significantly lower in the vegan group than in the meat-rich group (PRAL: 18.78 (21.04) and NEAPR 60.93 ± 15.51, respectively). Effects were mediated by a lower phosphorus and protein intake in the vegan group. Our study suggests that a vegan diet is a potential means to reduce DAL, whereas a meat-rich diet substantially increases the DAL burden.
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Digital messaging to support control for type 2 diabetes (StAR2D): a multicentre randomised controlled trial.
Farmer, A, Bobrow, K, Leon, N, Williams, N, Phiri, E, Namadingo, H, Cooper, S, Prince, J, Crampin, A, Besada, D, et al
BMC public health. 2021;21(1):1907
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Many individuals with type 2 diabetes find it challenging to adhere to treatments possibly due to lack of support. Text messaging has been shown to be effective for treatment adherence in various parts of the world, yet it is unclear on its effect in Malawi and sub-Saharan Africa. The aim of this randomised control trial of 1186 individuals was to determine the effect of motivational and educational text messages three to four times per week for 12 months on treatment success. The results showed that SMS text messages resulted in improved blood pressure and achievement of treatment goals, yet no effect on blood sugar control. It was concluded that text messaging without other support from health care professionals may be inadequate for the self-management of type 2 diabetes. This study could be used by health care professionals to understand that there are additional support strategies for individuals with type 2 diabetes, yet these should be secondary to the input from professionals.
Abstract
BACKGROUND Failure to take medicines for diabetes as prescribed contributes to poor outcomes from the condition. Mobile phones are ubiquitous and short message service (SMS) texts have shown promise as a low-cost intervention. We tested the effectiveness of SMS-text messaging in improving outcomes in adults with type 2 diabetes. METHODS StAR2D was a 12-month two-arm randomised trial of SMS-text messaging and usual care in Cape Town, South Africa and Lilongwe, Malawi. Messages used behaviour change theory and were developed with patients and staff. The intervention group received four messages each week. The primary outcome was change in HbA1c. Secondary outcomes were the proportion of patients who collected > 80% medication and changes in systolic blood pressure, lipids, cardiovascular risk, and the proportion of the participants reaching treatment goals. RESULTS The trial took place between 1 October, 2016 and 1 October 2018, 1186 participants were randomised to intervention (593) and control (593) groups. 91% of participants completed follow-up. There was a reduction in HbA1c (DCCT) in both groups but not in mean change (95% CI) between groups (- 0.08% (- 0.31 to 0.16) (IFCC - 0.82 mmol/mol (- 3.44 to 1.79). There was a small but not significant increase in the proportions of participants likely to have collected 80% or more of medication (Relative risk 1.11 (0.84 to 1.47; P = 0.47). There was a significant difference between groups in change in systolic blood pressure from baseline of 3.46 mmHg (1.48 to 5.44, P = 0.001) in favour of the intervention group. The between group difference in change in 10-year risk of coronary heart disease was - 0.71% (- 1.46 to 0.04, P = 0.064). The proportion of participants meeting treatment goals in the intervention group was 36.0% and in the control group 26.8% (Relative risk 1.36 (1.13 to 1.63, P = 0.001). Participants reported many challenges to adherence despite finding messages acceptable and useful. CONCLUSIONS Whilst SMS text messages do not lead to improved glycaemia in these low-resource settings there appeared to be an impact on blood pressure and achievement of treatment goals but the mechanisms for this are unclear. Text messages alone, may be unsuccessful unless accompanied by health system strengthening and other forms of self-management support for type 2 diabetes. TRIAL REGISTRATION Trial registration: ISRCTN, ISRCTN70768808. Registered 1 July 2015, http://www.isrctn.com/I ISRCTN70768808.
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Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial.
Vargas-Ortiz, K, Lira-Mendiola, G, Gómez-Navarro, CM, Padilla-Estrada, K, Angulo-Romero, F, Hernández-Márquez, JM, Villa-Martínez, AK, González-Mena, JN, Macías-Cervantes, MH, Reyes-Escogido, ML, et al
BMC public health. 2020;20(1):97
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In individuals at high risk of type 2 diabetes, lifestyle interventions rather than medication have been more successful in preventing development of the disease, however the benefits of lifestyle strategies diminishes over time due to possible adherence issues. Prolonged lifestyle changes may be affected by lack of family support, but research on family support during lifestyle changes in individuals prior to diabetes is lacking. This parallel randomised control trial of 122 patients with prediabetes and 101 of their family members aimed to assess the impact of family supported diet and exercise changes compared to self-motivation on individuals with prediabetes. At 6 months, body measurements and markers of prediabetes improved in both groups. Lipids were significantly improved in the group with family support compared to having no support. At 12 months there were a high number of dropouts due to lack of patient interest. Benefits shown at 6 months in both groups were only maintained or improved upon with family support and the lipid profile of the individual intervention group actually worsened in comparison to when participants entered the trial. After 12 months the incidence rate of type 2 diabetes was similar in both groups. Individuals with prediabetes who had family support whilst undergoing a diet and exercise regime were more successful at maintaining improvements of factors contributing to diabetes, compared to individuals without support. However this did not affect the occurrence of type 2 diabetes. Clinicians could use this paper to communicate the importance of family support during lifestyle changes in patients at high risk of developing type 2 diabetes, although close monitoring may be required to ensure compliance.
Abstract
BACKGROUND Lifestyle changes can reduce the risk of T2D; however, no study has evaluated the effect of a lifestyle intervention involving patients´ family. The aim of this study was to compare the impact of an interdisciplinary family (FI) Vs individual intervention (II) on glucose metabolism, insulin resistance (IR), pancreatic β-cell function and cardiovascular risk markers in patients with prediabetes, as well as to measure the impact on their families' metabolic risk. METHODS Randomized Clinical Trial (RCT) to compare the impact of FI and II on IR and pancreatic β-cell function in subjects with prediabetes. There were 122 subjects with prediabetes (and 101 family members) randomized to FI or II. Data were collected in 2015-2016 and analyzed in 2017-2018. FI group had the support of their family members, who also received personalized diet and exercise recommendations; patients and their family members attended monthly a lifestyle enhancement program. II group received personalized diet and exercise recommendations. The follow-up was for 12 months. Glucose, IR, pancreatic β-cell function and secondary outcomes (body composition and lipid profile) were assessed at baseline, 6 and 12 months. RESULTS FI group improved area under the glucose curve (AUC) (from 18,597 ± 2611 to 17,237 ± 2792, p = 0.004) and the Matsuda index (from 3.5 ± 2.3 to 4.7 ± 3.5, p = 0.05) at 12 months. II group improved Disposition Index (from 1.5 ± 0.4 to 1.9 ± 0.73, p < .0001) at 12 months. The improvements achieved in weight and lipids at 6 months, were lost in II group at 12 moths, whereas in FI persisted. Adherence up to 12 months was not different between the study groups (FI 56% Vs II 60%). CONCLUSIONS FI intervention was more effective by improving glucose AUC, insulin sensitivity and lipid profile, besides that, metabolic risk in family members of the FI group was maintained, while the risk of II group was increased. TRIAL REGISTRATION This study was retrospectively registered at clinicaltrials.gov on December 15, 2015 (NTC026365646).
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Eating self-efficacy changes in individuals with type 2 diabetes following a structured lifestyle intervention based on the transcultural Diabetes Nutrition Algorithm (tDNA): A secondary analysis of a randomized controlled trial.
Gilcharan Singh, HK, Chee, WSS, Hamdy, O, Mechanick, JI, Lee, VKM, Barua, A, Mohd Ali, SZ, Hussein, Z
PloS one. 2020;15(11):e0242487
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There is an increasing prevalence of type 2 diabetes (T2D) in Malaysia, which has led to the adoption of the global trans-cultural diabetes nutrition algorithm (tDNA), to better manage patients with T2D. Eating self-efficacy is the confidence an individual has to perform specific tasks and attain certain goals in challenging situations. This secondary analysis of a randomised control trial of 230 obese or T2D patients, aimed to determine the changes in eating self-efficacy when on tDNA over 12 months. The results showed improved eating self-efficacy with tDNA, which was further improved if individuals received both tDNA and motivational counselling. There was also greater weight loss and improvements to measures of diabetes in individuals who had a higher eating self-efficacy. However, it should be noted that nearly 18% of people dropped out of the trial. It was concluded that eating self-efficacy was improved in patients who followed a structured lifestyle intervention, and this also translated into greater weight loss and better improvements to diabetes. Health care professionals could use this study to understand that eating self-efficacy is an important behavioural component to care of patients with T2D and that structured lifestyle interventions may be more effective.
Abstract
OBJECTIVE Eating self-efficacy behavior is an important predictor of successful lifestyle intervention. This secondary analysis evaluated the changes in eating self-efficacy behavior in patients with type 2 diabetes (T2D) and overweight/obesity following structured lifestyle intervention based on the Malaysian customized transcultural Diabetes Nutrition Algorithm (tDNA). METHODS Patients with T2D and overweight/obesity (n = 230) were randomized either into the tDNA group which included a structured low-calorie meal plan using normal foods, incorporation of diabetes-specific meal replacements, and an exercise prescription or usual T2D care (UC) for 6 months. Patients in the tDNA group also received either counseling with motivational interviewing (tDNA-MI) or conventional counseling (tDNA-CC). The UC group received standard dietary and exercise advice using conventional counseling. Eating self-efficacy was assessed using a locally validated Weight Efficacy Lifestyle (WEL) questionnaire. All patients were followed up for additional 6 months' post-intervention. RESULTS There was a significant change in WEL scores with intervention over one-year [Group X Time effect: F = 51.4, df = (3.4, 318.7), p<0.001]. Compared to baseline, WEL scores improved in both the tDNA groups with significantly higher improvement in the tDNA-MI group compared to the tDNA-CC and UC groups at 6 months (tDNA-MI: 25.4±2.1 vs. tDNA-CC: 12.9±2.8 vs. UC: -6.9±1.9, p<0.001). At 12 months' follow-up, both the tDNA groups maintained improvement in the WEL scores, with significantly higher scores in the tDNA-MI group than tDNA-CC group, and the UC group had decreased WEL scores (tDNA-MI: 28.9±3.1 vs. tDNA-CC: 11.6±3.6 vs. UC: -13.2±2.1, p<0.001). Patients in the tDNA-MI group with greater weight loss and hemoglobin A1C reduction also had a higher eating self-efficacy, with a similar trend observed in comparative groups. CONCLUSION Eating self-efficacy improved in patients with T2D and overweight/obesity who maintained their weight loss and glycemic control following a structured lifestyle intervention based on the Malaysian customized tDNA and the improvement was further enhanced with motivational interviewing. CLINICAL TRIAL This randomized clinical trial was registered under National Medical Research Registry, Ministry of Health Malaysia with registration number: NMRR-14-1042-19455 and also under ClinicalTrials.gov with registration number: NCT03881540.
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Comparison of two low-fat diets, differing in protein and carbohydrate, on psychological wellbeing in adults with obesity and type 2 diabetes: a randomised clinical trial.
Watson, NA, Dyer, KA, Buckley, JD, Brinkworth, GD, Coates, AM, Parfitt, G, Howe, PRC, Noakes, M, Murphy, KJ
Nutrition journal. 2018;17(1):62
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The psychological burden of living with type 2 diabetes (T2D) has far reaching effects, negatively impacting quality of life, physical health and emotional wellbeing. It has been suggested that health-related quality of life (HRQoL) changes in response to weight status however this has not yet been explored in individuals with T2D. The aim of this randomised controlled study was to compare the effects of high protein and high carbohydrate diets, combined with moderate intensity exercise, on psychological wellbeing and HRQoL in 61 overweight adults with T2D. Participants enrolled in a 12-week weight loss period followed by a 12-week weight maintenance phase and blood glucose levels and various quality of life factors were assessed. This trial found in overweight adults with T2D, improvements in several psychological wellbeing and HRQoL were seen in response to modest weight loss and improvements in blood sugar levels. Improvements were seen in both high protein and high carbohydrate group, though a high protein diet may be better for maintaining control of blood glucose levels thus improving feelings of vitality. Based on this study, the authors conclude that it is imperative to address and support the psychological aspects of patients managing T2D.
Abstract
BACKGROUND Although higher-protein diets (HP) can assist with weight loss and glycemic control, their effect on psychological wellbeing has not been established. The objective of this study was to compare the effects of a HP and a higher-carbohydrate diet (HC), combined with regular exercise, on psychological wellbeing both during weight loss (WL) and weight maintenance phases (WM). METHODS In a parallel RCT, 61 adults with T2D (mean ± SD: BMI 34.3 ± 5.1 kg/m2, aged 55 ± 8 years) consumed a HP diet (29% protein, 34% carbohydrate, 31% fat) or an isocaloric HC diet (21%:48%:24%), with moderate intensity exercise, for 12 weeks of WL and 12 weeks of WM. Secondary data evaluating psychological wellbeing was assessed using: Problems Areas in Diabetes (PAID); Diabetes-39 Quality of Life (D-39); Short Form Health Survey (SF-36); Perceived Stress Scale-10 (PSS-10) and the Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 0, 12 and 24 and evaluated with mixed models analysis. RESULTS Independent of diet, improvements for PAID; D-39 diabetes control; D-39 severity of diabetes; SF-36 physical functioning and SF-36 general health were found following WL (d = 0.30 to 0.69, P ≤ 0.04 for all) which remained after 12 weeks of WM. SF-36 vitality improved more in the HP group (group x time interaction P = 0.03). Associations were seen between HbA1c and D-39 severity of diabetes rating (r = 0.30, P = 0.01) and SF-36 mental health (r = - 0.32, P = 0.003) and between weight loss and PAID (r = 0.30, P = 0.01). CONCLUSION Several improvements in diabetes-related and general psychological wellbeing were seen similarly for both diets following weight loss and a reduction in HbA1c with most of these improvements remaining when weight loss was sustained for 12 weeks. A HP diet may provide additional increases in vitality. TRIAL REGISTRATION The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN 12613000008729 ) on 4 January 2013.
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Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial.
Lean, ME, Leslie, WS, Barnes, AC, Brosnahan, N, Thom, G, McCombie, L, Peters, C, Zhyzhneuskaya, S, Al-Mrabeh, A, Hollingsworth, KG, et al
Lancet (London, England). 2018;391(10120):541-551
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Most individuals with type 2 diabetes are obese with accumulation of fat around the liver and pancreas. Many studies have demonstrated that dietary induced weight loss can improve type 2 diabetes, however none have assessed whether dietary weight loss can sustain type 2 diabetes remission. This 12-month randomised trial of 306 individuals with type 2 diabetes aimed to determine whether weight management led by doctors would achieve long-term remission of type 2 diabetes. The results showed that weight loss of 15kg or more resulted in significantly higher rates of type 2 diabetes remission after 12 months, with 48% of the weight loss group achieving remission compared to 4% of the individuals who were not assigned a weight loss regimen. It was concluded that nearly half of the participants who were on a dietary weight loss programme achieved type 2 diabetes remission and were able to stop their medications. This study could be used by healthcare professionals to understand that type 2 diabetes remission is a possibility with a supervised dietary weight loss programme.
Abstract
BACKGROUND Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes. METHODS We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20-65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27-45 kg/m2, and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825-853 kcal/day formula diet for 3-5 months), stepped food reintroduction (2-8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA1c) of less than 6·5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. These outcomes were analysed hierarchically. This trial is registered with the ISRCTN registry, number 03267836. FINDINGS Between July 25, 2014, and Aug 5, 2017, we recruited 306 individuals from 49 intervention (n=23) and control (n=26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, we recorded weight loss of 15 kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0·0001). Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19·7, 95% CI 7·8-49·8; p<0·0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, six (7%) of 89 participants who maintained 0-5 kg weight loss, 19 (34%) of 56 participants with 5-10 kg loss, 16 (57%) of 28 participants with 10-15 kg loss, and 31 (86%) of 36 participants who lost 15 kg or more. Mean bodyweight fell by 10·0 kg (SD 8·0) in the intervention group and 1·0 kg (3·7) in the control group (adjusted difference -8·8 kg, 95% CI -10·3 to -7·3; p<0·0001). Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7·2 points (SD 21·3) in the intervention group, and decreased by 2·9 points (15·5) in the control group (adjusted difference 6·4 points, 95% CI 2·5-10·3; p=0·0012). Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, were deemed potentially related to the intervention. No serious adverse events led to withdrawal from the study. INTERPRETATION Our findings show that, at 12 months, almost half of participants achieved remission to a non-diabetic state and off antidiabetic drugs. Remission of type 2 diabetes is a practical target for primary care. FUNDING Diabetes UK.
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Resveratrol Ameliorates Arterial Stiffness Assessed by Cardio-Ankle Vascular Index in Patients With Type 2 Diabetes Mellitus.
Imamura, H, Yamaguchi, T, Nagayama, D, Saiki, A, Shirai, K, Tatsuno, I
International heart journal. 2017;58(4):577-583
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Resveratrol, a polyphenol found in grapes and red wine, has been shown to have significant positive effects on arterial stiffness in animal studies. This randomised placebo controlled, double blind trial is one of the first looking at the effects of oral resveratrol on arterial stiffness in humans with Type 2 diabetes. 50 study participants attending a diabetes clinic were randomised to receive 100mg of resveratrol or placebo for 12 weeks. To measure changes to arterial stiffness, the study used a method called the Cardio-ankle vascular index which was measured at the start and end of the study. Other measures included blood pressure, body weight, glucose and lipid markers, and a marker of oxidative stress. The authors found that resveratrol supplementation reduced blood pressure, oxidative stress and arterial stiffness significantly and body weight marginally over the 12 weeks of the study. The authors conclude that supplementation with resveratrol at 100mg daily may have beneficial effects on arterial stiffness, oxidative stress and blood pressure in patients with Type 2 diabetes. A large scale trial is required to validate these findings.
Abstract
Resveratrol has been reported to have potent anti-atherosclerotic effects in animal studies. However, there are few interventional studies in human patients with atherosclerogenic diseases. The cardio-ankle vascular index (CAVI) reflects arterial stiffness and is a clinical surrogate marker of atherosclerosis. The aim of the present study was to investigate the effect of resveratrol on arterial stiffness assessed by CAVI in patients with type 2 diabetes mellitus (T2DM).In this double-blind, randomized, placebo-controlled study, 50 patients with T2DM received supplement of a 100mg resveratrol tablet (total resveratrol: oligo-stilbene 27.97 mg/100 mg/day) or placebo daily for 12 weeks. CAVI was assessed at baseline and the end of study. Body weight (BW), blood pressure (BP), glucose and lipid metabolic parameters, and diacron-reactive oxygen metabolites (d-ROMs; an oxidative stress marker) were also measured.Resveratrol supplementation decreased systolic BP (-5.5 ± 13.0 mmHg), d-ROMs (-25.6 ± 41.8 U.CARR), and CAVI (-0.4 ± 0.7) significantly (P < 0.05) and decreased BW (-0.8 ± 2.1 kg, P = 0.083) and body mass index (-0.5 ± 0.8 kg/m2, P = 0.092) slightly compared to baseline, while there were no significant changes in the placebo group. Decreases in CAVI and d-ROMs were significantly greater in the resveratrol group than in the placebo group. Multivariate logistic regression analysis identified resveratrol supplementation as an independent predictor for a CAVI decrease of more than 0.5.In conclusion, 12-week resveratrol supplementation may improve arterial stiffness and reduce oxidative stress in patients with T2DM. Resveratrol may be beneficial in preventing the development of atherosclerosis induced by diabetes. However, a large-scale cohort study is required to validate the present findings.