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Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).
Represas-Carrera, F, Couso-Viana, S, Méndez-López, F, Masluk, B, Magallón-Botaya, R, Recio-Rodríguez, JI, Pombo, H, Leiva-Rus, A, Gil-Girbau, M, Motrico, E, et al
International journal of environmental research and public health. 2021;18(11)
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Life habits such as smoking, physical activity, and diet affect glycaemic control. The objective of this multicentre randomised cluster trial (EIRA study) was to evaluate the effectiveness of multicomponent educational interventions on glycaemic control in Type 2 diabetic patients. Interventions in multicomponent individual, group and community settings included smoking cessation, the Mediterranean diet and physical activity, as well as an assessment of the quality of life. Participants had unhealthy lifestyles prior to the intervention. The study was conducted in 26 primary healthcare centres in seven health departments in Spain over a period of 12 months. A brief intervention aimed to change the habits of the participants, including increasing physical activity, quitting smoking and adhering to the Mediterranean diet. After 12 months of intervention, there were no statistically significant improvements in glycaemic control, physical activity, sedentary lifestyle, smoking, or quality of life. However, adherence to the Mediterranean diet was statistically significant. Further research is needed to determine the effectiveness of multicomponent interventions in improving glycaemic control. The clinical applicability of multicomponent interventions to tackle type 2 diabetes, obesity, and unhealthy lifestyles should be considered by healthcare providers.
Abstract
Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.
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Effects of A 12-Month Intensive Lifestyle Monitoring Program in Predominantly Overweight/Obese Arab Adults with Prediabetes.
Wani, K, Alfawaz, H, Alnaami, AM, Sabico, S, Khattak, MNK, Al-Attas, O, Alokail, MS, Alharbi, M, Chrousos, G, Kumar, S, et al
Nutrients. 2020;12(2)
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Key determinant factors associated with type 2 diabetes mellitus in the Arab world, aside from the genetic predisposition are obesity, rapid urbanization, and lack of physical activity. The aim of the study was to evaluate the effectiveness of a Diabetes Prevention Programme-based lifestyle modification program focused on overweight/obese Saudi adults with impaired fasting glucose. This study is a 12-month two-arm randomized controlled (1:1) lifestyle intervention. Participants were randomly assigned to receive either an intensive lifestyle modification program or general advice at the time of recruitment. Results showed that participants following the intensive lifestyle modification program had significant changes in body weight, body mass index and glycaemic indices post-intervention. Authors conclude that for Saudi adults with impaired fasting glucose, a self-monitoring-based lifestyle intervention may be a significant tool for weight loss and to reverse to normoglycemia [normal concentration of sugar in the blood].
Abstract
This 12-month, randomized, controlled lifestyle intervention study was aimed at assessing the effectiveness of a lifestyle intervention in terms of (1) the reduction of at least 5% of body weight compared to baseline and (2) the percentage of participants in which fasting blood glucose (FBG) normalizes (<5.6 mmol/L) post-intervention, in predominantly overweight/obese Saudi adults with impaired fasting glucose. A total of 300 Saudi adults with prediabetes at baseline (FBG 5.6-6.9 mmol/L) were enrolled to receive either general advice (GA) or a rigorous, self-monitored, lifestyle modification program (intervention group, IG) for 12 months, focused on food choices, physical activity, and weight loss. Anthropometric and biochemical estimations were analyzed at baseline, 6, and 12 months. At baseline, 136/150 in the GA group (90.7%) and 127/150 in the IG group (84.7%) were either overweight or obese. A total of 14% (n = 21) of the subjects in the IG arm discontinued, compared to 8% (n = 12) in the GA arm. Data from completers (92% (n = 138) and 86% (n= 129) participants in GA and IG arms, respectively) were considered for the final analysis. Post-intervention, 37.2% (n = 48) of participants in the IG group had ≥5% weight reduction, as compared to 12.3% (n = 17) in the GA group (p < 0.01). Similarly, the percentage of participants who normalized their FBG post-intervention was 46.5% (n = 60) in the IG group compared to 21.7% (n = 30) in the GA group (p < 0.01). A 12-month Diabetes Prevention Program (DPP)-styled intensive lifestyle program translated effectively in decreasing weight and improving fasting glucose compared to the GA group in predominantly overweight/obese Saudi adults with prediabetes, suggesting that in the case of guided intervention programs, people are willing to participate and possibly change a sedentary lifestyle.
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Effectiveness of an Intervention of Dietary Counseling for Overweight and Obese Pregnant Women in the Consumption of Sugars and Energy.
Anleu, E, Reyes, M, Araya B, M, Flores, M, Uauy, R, Garmendia, ML
Nutrients. 2019;11(2)
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Excessive weight during pregnancy and maternal obesity are associated with health complications. Long-term complications include the appearance of obesity and noncommunicable diseases in both mother and child. The aim of the study was to evaluate whether dietary counselling decreased the consumption of total sugars and energy, compared to their consumption before the intervention and compared to women who only received routine counselling. The study is an experimental study that compared the intervention group (n = 272) to the control group (n = 161). The former received dietary counselling whilst the latter received the routine control recommendations. The study population consisted of overweight or obese pregnant women. Results indicate that an intervention with dietary counselling in overweight or obese pregnant women was effective in decreasing the consumption of foods that most contribute to total sugars, energy, and the percentage of energy from sugars. Authors conclude that the implementation of a dietary intervention with nutritional counselling focused on sugars consumption, decreased the consumption of energy and total sugars in overweight and obese pregnant women, mainly in the foods groups high in free sugars.
Abstract
OBJECTIVE Evaluate if an intervention based on nutritional counseling decreases total sugars and energy consumption in overweight and obese pregnant women, compared to their previous consumption and compared to women who only received routine counseling. METHODS Randomized study of two groups: dietary counseling (Intervention Group: IG) and routine counseling (Control Group: CG). The intervention consisted of three educational sessions focused on decreasing intake of foods that most contribute to sugars consumption. Changes in sugars and energy consumption were evaluated by a food frequency questionnaire before and after the intervention. RESULTS We evaluated 433 pregnant women, 272 in IG and 161 in CG, who before intervention had a mean consumption of 140 g total sugars and 2134 kcal energy per day. At the end of the intervention, the IG showed 15 g/day lower consumption of total sugars (95% CI: -25 and -5 g/day), 2% less total energy from sugars (95% CI: -3% and -1% g/day), and 125 kcal/day less energy than the CG (95% CI: -239 and -10 kcal/day). Table sugar, sweets, and soft drinks had the greatest reduction in consumption. CONCLUSIONS The intervention focused on counseling on the decrease in consumption of the foods that most contribute to sugars consumption in overweight and obese pregnant women was effective in decreasing total sugars and energy consumption, mainly in the food groups high in sugars. Future studies should examine if this intervention has an effect on maternal and fetal outcomes.
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Dietary fiber intake and glycemic control: coronary artery calcification in type 1 diabetes (CACTI) study.
Basu, A, Alman, AC, Snell-Bergeon, JK
Nutrition journal. 2019;18(1):23
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The incidence of type 1 diabetes and cardiovascular disease, the major vascular complication of diabetes, have been increasing wordwide. The aim of the study is to identify the associations of dietary fibre with glycaemic control. The study is a cross-sectional longitudinal study which enrolled 1257 individuals in the cross-sectional analysis and a total of 990 participants were included in the longitudinal analysis. The participants had no known history of coronary heart disease. Results indicate an inverse association between total fibre intake and the average blood glucose levels for the last two to three months in both diabetic and nondiabetic participants. Authors conclude that their study provides some evidence on the role dietary fibre intake plays on glycaemic control, which is important in the management of type 1 diabetes in patients at high risk of cardiovascular disease.
Abstract
BACKGROUND Dietary fiber has been recommended for glucose control, and typically low intakes are observed in the general population. The role of fiber in glycemic control in reported literature is inconsistent and few reports are available in populations with type 1 diabetes (T1D). METHODS Using data from the Coronary Artery Calcification in Type 1 Diabetes (CACTI) study [n = 1257; T1D: n = 568; non-diabetic controls: n = 689] collected between March 2000 and April 2002, we examined cross-sectional (baseline) and longitudinal (six-year follow-up in 2006-2008) associations of dietary fiber and HbA1c. Participants completed a validated food frequency questionnaire, and a physical examination and fasting biochemical analyses (12 h fast) at baseline visit and at the year 6 visit. We used a linear regression model stratified by diabetes status, and adjusted for age, sex and total calories, and diabetes duration in the T1D group. We also examined correlations of dietary fiber with HbA1c. RESULTS Baseline dietary fiber intake and serum HbA1c in the T1D group were 16 g [median (IQ): 11-22 g) and 7.9 ± 1.3% mean (SD), respectively, and in the non-diabetic controls were 15 g [median (IQ): 11-21 g) and 5.4 ± 0.4%, respectively. Pearson partial correlation coefficients revealed a significant but weak inverse association of total dietary fiber with HbA1c when adjusted for age, sex, diabetes status and total calories (r = - 0.07, p = 0.01). In the adjusted linear regression model at baseline, total dietary fiber revealed a significant inverse association with HbA1c in the T1D group [β ± SE = - 0.32 ± 0.15, p = 0.034], as well as in the non-diabetic controls [- 0.10 ± 0.04, p = 0.009]. However, these results were attenuated after adjustment for dietary carbohydrates, fats and proteins, or for cholesterol and triglycerides. No such significance was observed at the year 6 follow-up, and with the HbA1c changes over 6 years. CONCLUSION Thus, at observed levels of intake, total dietary fiber reveals modest inverse associations with poor glycemic control. Future studies must further investigate the role of overall dietary quality adjusting for fiber-rich foods in T1D management.
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Vegetarian diets and risk of hospitalisation or death with diabetes in British adults: results from the EPIC-Oxford study.
Papier, K, Appleby, PN, Fensom, GK, Knuppel, A, Perez-Cornago, A, Schmidt, JA, Tong, TYN, Key, TJ
Nutrition & diabetes. 2019;9(1):7
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The identification of modifiable risk factors is vital for the reduction of the growing diabetes epidemic. Diet is one such lifestyle factor that might play a key role in the prevention of diabetes. The aim of the study was to investigate the association between vegetarianism and diabetes in a large, population-based study of British adults. The study is a prospective study of vegetarianism and diabetes risk in a cohort of 45,314 participants. Results indicate that the low meat eaters, fish eaters and vegetarians had a lower risk of developing diabetes compared to regular meat eaters. Authors conclude that people consuming a low or meat-free diet had a lower risk of hospitalisation or death with diabetes.
Abstract
BACKGROUND The global prevalence of diabetes is high and rapidly increasing. Some previous studies have found that vegetarians might have a lower risk of diabetes than non-vegetarians. OBJECTIVE We examined the association between vegetarianism and risk of hospitalisation or death with diabetes in a large, prospective cohort study of British adults. METHODS The analysed cohort included participants from the European Prospective Investigation into Cancer and Nutrition (EPIC)-Oxford study who were diabetes free at recruitment (1993-2001), with available dietary intake data at baseline, and linked hospital admissions and death data for diabetes over follow-up (n = 45,314). Participants were categorised as regular meat eaters (≥50 g per day: n = 15,181); low meat eaters (<50 g of meat per day: n = 7615); fish eaters (ate no meat but consumed fish: n = 7092); and vegetarians (ate no meat or fish, including vegans: n = 15,426). We used multivariable Cox proportional hazards models to assess associations between diet group and risk of diabetes. RESULTS Over a mean of 17.6 years of follow-up, 1224 incident cases of diabetes were recorded. Compared with regular meat eaters, the low meat eaters, fish eaters, and vegetarians were less likely to develop diabetes (hazard ratio (HR) = 0.63, 95% confidence interval (CI) 0.54-0.75; HR = 0.47, 95% CI 0.38-0.59; and HR = 0.63, 95% CI 0.54-0.74, respectively). These associations were substantially attenuated after adjusting for body mass index (BMI) (low meat eaters: HR = 0.78, 95% CI 0.66-0.92; fish eaters: HR = 0.64, 95% CI 0.51-0.80; and vegetarians: HR = 0.89, 95% CI 0.76-1.05). CONCLUSIONS Low meat and non-meat eaters had a lower risk of diabetes, in part because of a lower BMI.
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A 12-Month Lifestyle Intervention Program Improves Body Composition and Reduces the Prevalence of Prediabetes in Obese Patients.
König, D, Hörmann, J, Predel, HG, Berg, A
Obesity facts. 2018;11(5):393-399
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Obesity and its impact on the prevalence of diabetes and subsequent cardiovascular disease is one of the major health burdens in Western societies. Lifestyle intervention studies have shown that weight loss combined with increased physical activity can improve metabolic risk factors. The aim of this study was to evaluate the effect of a comprehensive lifestyle intervention programme on weight and metabolic risk factors in 5884 obese individuals. The programme included 61 sessions over 12 months, including 41 exercise sessions, 12 psychological/self-management sessions and 8 nutritional counselling sessions (based on a low glycaemic index, low fat diet). After 12 months there was a significant reduction in weight (average 6%), waist circumference, physical fitness and all metabolic parameters (including blood sugar and fat metabolism). Overall, in 839 (38%) of the 2,227 participants who were pre-diabetic before intervention, the criteria of pre-diabetes were no longer detectable after 12 months, whilst only 66 (3%) progressed to type 2 diabetes mellitus. 46.7% of the 1,641 participants fulfilling the criteria of metabolic syndrome before the intervention, did not show any signs of this syndrome after the intervention; whilst only 120 participants (+7.3%) newly developed metabolic syndrome. The authors concluded that the intensive lifestyle intervention programme was successful, even in obese people with pre-diabetes.
Abstract
BACKGROUND The present study investigated the effects of a 12-month interdisciplinary standardized lifestyle program addressing physical activity and changes in dietary and lifestyle behavior in 2,227 obese prediabetic participants. METHODS Measures of obesity (BMI, waist circumference), cardiopulmonary fitness, and metabolic parameters were determined before and after the intervention period. RESULTS From the 2,227 participants who were initially prediabetic, 839 participants (-37.7%) did no longer show the criteria of prediabetes after the intervention and had normal HbA1c levels. CONCLUSION The clinical effects are substantial, and it is likely that the applied intense and multidisciplinary lifestyle interventions could reduce the risk of developing diabetes and the prevalence of a full-blown metabolic syndrome in obese and prediabetic patients.
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The effect of a short-term low-carbohydrate, high-fat diet with or without postmeal walks on glycemic control and inflammation in type 2 diabetes: a randomized trial.
Myette-Côté, É, Durrer, C, Neudorf, H, Bammert, TD, Botezelli, JD, Johnson, JD, DeSouza, CA, Little, JP
American journal of physiology. Regulatory, integrative and comparative physiology. 2018;315(6):R1210-R1219
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Inflammation is associated with the pathogenesis of insulin resistance, type 2 diabetes (T2D), and related complications. Lifestyle therapy is a frontline treatment for improving glucose control in people with T2D. The main aim of this study was to determine whether reducing hyperglycaemia with a low-carbohydrate high-fat (LC) diet could lower markers of innate immune cell activation and systemic inflammation in people with T2D. A secondary aim was to examine if the combination of an LCHF diet with strategically timed postmeal walking was superior to an LCHF diet alone. The study is a randomised cross over study which enrolled Individuals with physician-diagnosed T2D to complete three short-term controlled-intervention periods. Sixteen participants were enrolled (men = 8 and women = 8) who were aged between 48 and 72 years. Results indicate that while LC and LC together with exercise (LC+Ex) led to superior improvements in glucose control and fasting proinsulin (the pro-hormone precursor to insulin) levels as compared with low-fat low glycaemic index diet (GL), all three diets (GL, LC and LC+Ex), appeared to lower a particular marker of cellular inflammation over the short-term. Authors conclude that an LCHF diet with or without daily postmeal walks improved four-day glycaemic control and fasting proinsulin levels compared with a GL diet.
Abstract
Lowering carbohydrate consumption effectively lowers glucose, but impacts on inflammation are unclear. The objectives of this study were to: 1) determine whether reducing hyperglycemia by following a low-carbohydrate, high-fat (LC) diet could lower markers of innate immune cell activation in type 2 diabetes (T2D) and 2) examine if the combination of an LC diet with strategically timed postmeal walking was superior to an LC diet alone. Participants with T2D ( n = 11) completed a randomized crossover study involving three 4-day diet interventions: 1) low-fat low-glycemic index (GL), 2) and 3) LC with 15-min postmeal walks (LC+Ex). Four-day mean glucose was significantly lower in the LC+Ex group as compared with LC (-5%, P < 0.05), whereas both LC+Ex (-16%, P < 0.001) and LC (-12%, P < 0.001) conditions were lower than GL. A significant main effect of time was observed for peripheral blood mononuclear cells phosphorylated c-Jun N-terminal kinase ( P < 0.001), with decreases in all three conditions (GL: -32%, LC: -45%, and LC+Ex: -44%). A significant condition by time interaction was observed for monocyte microparticles ( P = 0.040) with a significant decrease in GL (-76%, P = 0.035) and a tendency for a reduction in LC (-70%, P = 0.064), whereas there was no significant change in LC+Ex (0.5%, P = 0.990). Both LC (-27%, P = 0.001) and LC+Ex (-35%, P = 0.005) also led to significant reductions in circulating proinsulin. An LC diet improved 4-day glycemic control and fasting proinsulin levels when compared with GL, with added glucose-lowering benefits when LC was combined with postmeal walking.
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Carbohydrate restriction with postmeal walking effectively mitigates postprandial hyperglycemia and improves endothelial function in type 2 diabetes.
Francois, ME, Myette-Cote, E, Bammert, TD, Durrer, C, Neudorf, H, DeSouza, CA, Little, JP
American journal of physiology. Heart and circulatory physiology. 2018;314(1):H105-H113
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Prevention of cardiovascular disease in individuals with type 2 diabetes (T2D) is a major treatment goal. Within this, diet and exercise remain the cornerstone lifestyle therapies. The aim of this study was to examine the effects of 4 days of a low-carbohydrate diet, with or without daily post-meal walking, on vascular health in individuals with T2D. The study recruited sixteen individuals with physician-diagnosed T2D to complete 3 short-term controlled intervention periods in a randomised crossover design. Results indicate that attenuating postprandial hyperglycaemia (a very high rise in blood sugar following a meal) by restricting carbohydrates and post-meal walking can improve vascular health in individuals with T2D. Authors conclude that carbohydrate restriction and post-meal exercise may represent an effective strategy to mitigate the negative effects of postprandial hyperglycaemia and reduce cardiovascular disease risk in individuals with T2D.
Abstract
Postprandial hyperglycemia has deleterious effects on endothelial function. Restricting carbohydrate intake and postmeal walking have each been shown to reduce postprandial hyperglycemia, but their combination and subsequent effects on endothelial function have not been investigated. Here, we sought to examine the effect of blunting postprandial hyperglycemia by following a low-carbohydrate diet, with or without postmeal walking exercise, on markers of vascular health in type 2 diabetes (T2D). In a randomized crossover design, individuals with T2D ( n = 11) completed three 4-day controlled diet interventions consisting of 1) low-carbohydrate diet alone (LC), 2) low-carbohydrate diet with 15-min postmeal walks (LC + Ex), and 3) low-fat control diet (CON). Fasting blood samples and brachial artery flow-mediated dilation (%FMD) were measured before and after each intervention. Total circulating microparticles (MPs), endothelial MPs, platelet MPs, monocyte-platelet aggregates, and adhesion molecules were assessed as biomarkers of vascular health. There was a significant condition × time interaction for %FMD ( P = 0.01), with post hoc tests revealing improved %FMD after LC + Ex (+0.8 ± 1.0%, P = 0.02), with no change after LC or CON. Endothelial MPs were significantly reduced with the LC diet by ~45% (from 99 ± 60 to 44 ± 31 MPs/μl, P = 0.02), with no change after LC + Ex or CON (interaction: P = 0.04). Total MPs were lower (main effect time: P = 0.02), whereas monocyte-platelet aggregates were higher (main effect time: P < 0.01) after all interventions. Plasma adhesion molecules and C-reactive protein were unaltered. Attenuating postprandial hyperglycemic excursions using a low-carbohydrate diet combined with postmeal walking appears to be an effective strategy to improve endothelial function in individuals with T2D. NEW & NOTEWORTHY Carbohydrate restriction and postmeal walking lower postprandial hyperglycemia in individuals with type 2 diabetes. Here, we show that the combination significantly improved endothelial function and that carbohydrate restriction alone reduced circulating endothelial microparticles in individuals with type 2 diabetes. Listen to this article's corresponding podcast at http://ajpheart.podbean.com/e/low-carb-diet-and-exercise-improve-endothelial-health/ .
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A Plant-Based High-Carbohydrate, Low-Fat Diet in Overweight Individuals in a 16-Week Randomized Clinical Trial: The Role of Carbohydrates.
Kahleova, H, Dort, S, Holubkov, R, Barnard, ND
Nutrients. 2018;10(9)
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The prevalence of obesity has reached epidemic proportions. As a result, the risk of obesity-related diseases is rapidly increasing, and increased body weight is associated with a higher all-cause mortality. The aim of the study is to determine whether high carbohydrate and fibre intakes in the context of a plant-based diet are associated with weight loss, reduction in fat mass, and decrease in insulin resistance. The study is a single-centre, randomised controlled study. The participants recruited for the study were adults with a BMI between 28 and 40 kg/m2. Results demonstrated that increased consumption of carbohydrates and dietary fibre, as part of a plant-based high-carbohydrate, low-fat diet, was associated with reduced body weight, fat mass, and insulin resistance in overweight individuals. Authors conclude that increased consumption of total carbohydrates and total fibre, particularly insoluble fibre, was linked with lower body mass index and volume in visceral fat. Furthermore, increased fibre intake is also associated with decrease in fat mass.
Abstract
The effects of carbohydrates on body weight and insulin sensitivity are controversial. In this 16-week randomized clinical trial, we tested the role of a low-fat, plant-based diet on body weight, body composition and insulin resistance. As a part of this trial, we investigated the role of changes in carbohydrate intake on body composition and insulin resistance. Participants (n = 75) were randomized to follow a plant-based high-carbohydrate, low-fat (vegan) diet (n = 38) or to maintain their current diet (n = 37). Dual-energy X-ray absorptiometry was used to measure body composition. Insulin resistance was assessed with the Homeostasis Model Assessment (HOMA-IR) index. A repeated measure ANOVA model was used to test the between-group differences from baseline to 16 weeks. A linear regression model was used to test the relationship between carbohydrate intake, and body composition and insulin resistance. Weight decreased significantly in the vegan group (treatment effect -6.5 [95% CI -8.9 to -4.1] kg; Gxt, p < 0.001). Fat mass was reduced in the vegan group (treatment effect -4.3 [95% CI -5.4 to -3.2] kg; Gxt, p < 0.001). HOMA-IR was reduced significantly in the vegan group (treatment effect -1.0 [95% CI -1.2 to -0.8]; Gxt, p = 0.004). Changes in consumption of carbohydrate, as a percentage of energy, correlated negatively with changes in BMI (r = -0.53, p < 0.001), fat mass (r = -0.55, p < 0.001), volume of visceral fat (r = -0.35, p = 0.006), and HOMA (r = -0.27, p = 0.04). These associations remained significant after adjustment for energy intake. Changes in consumption of total and insoluble fiber correlated negatively with changes in BMI (r = -0.43, p < 0.001; and r = -0.46, p < 0.001, respectively), fat mass (r = -0.42, p < 0.001; and r = -0.46, p < 0.001, respectively), and volume of visceral fat (r = -0.29, p = 0.03; and r = -0.32, p = 0.01, respectively). The associations between total and insoluble fiber and changes in BMI and fat mass remained significant even after adjustment for energy intake. Increased carbohydrate and fiber intake, as part of a plant-based high-carbohydrate, low-fat diet, are associated with beneficial effects on weight, body composition, and insulin resistance.
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Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.
Johansen, MY, MacDonald, CS, Hansen, KB, Karstoft, K, Christensen, R, Pedersen, M, Hansen, LS, Zacho, M, Wedell-Neergaard, AS, Nielsen, ST, et al
JAMA. 2017;318(7):637-646
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First-line treatment of Type 2 diabetes includes diet, physical activity, and weight loss prior to or in parallel with initiation of medication. The aim of this study was to examine whether an intensive lifestyle intervention results in equivalent blood sugar control compared with standard care. A secondary aim was to test whether an intensive lifestyle intervention leads to a reduction in glucose-lowering medication in participants with Type 2 diabetes. The study was a randomized, assessor-blind clinical study of 98 adults with Type 2 diabetes diagnosed for less than 10 years. The participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). Results show that an intensive lifestyle intervention did not achieve comparable blood sugar control in comparison with standard care, however, the former led to a substantial and parallel reduction in glucose-lowering medication. The authors conclude that even though a lifestyle intervention compared to standard care did not result in the expected glycaemic control, it was still in a direction consistent with benefit.
Abstract
Importance: It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes. Objective: To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes. Design, Setting, and Participants: Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). Interventions: All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months. Main Outcomes and Measures: Primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication. Results: Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group. Conclusions and Relevance: Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings. Trial Registration: clinicaltrials.gov Identifier: NCT02417012.