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Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial.

ABSTRACT: INTRODUCTION:Type 2 diabetes (T2DM) produces macrovascular and microvascular damage, significantly increasing the risk of cardiovascular disease (CVD), renal failure and blindness. As rates of T2DM rise, the need for effective dietary and other lifestyle changes to improve diabetes management become more urgent. Low-glycaemic index (GI) diets may improve glycaemic control in diabetes in the short term; however, there is a lack of evidence on the long-term adherence to low-GI diets, as well as on the association with surrogate markers of CVD beyond traditional risk factors. Recently, advances have been made in measures of subclinical arterial disease through the use of MRI, which, along with standard measures from carotid ultrasound (CUS) scanning, have been associated with CVD events. We therefore designed a randomised, controlled, clinical trial to assess whether low-GI dietary advice can significantly improve surrogate markers of CVD and long-term glycaemic control in T2DM. METHODS AND ANALYSIS:169 otherwise healthy individuals with T2DM were recruited to receive intensive counselling on a low-GI or high-cereal fibre diet for 3?years. To assess macrovascular disease, MRI and CUS are used, and to assess microvascular disease, retinal photography and 24-hour urinary collections are taken at baseline and years 1 and 3. Risk factors for CVD are assessed every 3?months. ETHICS AND DISSEMINATION:The study protocol and consent form have been approved by the research ethics board of St. Michael's Hospital. If the study shows a benefit, these data will support the use of low-GI and/or high-fibre foods in the management of T2DM and its complications. TRIAL REGISTRATION NUMBER:NCT01063374; Pre-results.

SUBMITTER: Chiavaroli L

PROVIDER: S-EPMC4947767 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial.

Chiavaroli Laura L Mirrahimi Arash A Ireland Christopher C Mitchell Sandra S Sahye-Pudaruth Sandhya S Coveney Judy J Olowoyeye Omodele O Maraj Tishan T Patel Darshna D de Souza Russell J RJ Augustin Livia S A LS Bashyam Balachandran B Blanco Mejia Sonia S Nishi Stephanie K SK Leiter Lawrence A LA Josse Robert G RG McKeown-Eyssen Gail G Moody Alan R AR Berger Alan R AR Kendall Cyril W C CW Sievenpiper John L JL Jenkins David J A DJ

BMJ open 20160707 7

<h4>Introduction</h4>Type 2 diabetes (T2DM) produces macrovascular and microvascular damage, significantly increasing the risk of cardiovascular disease (CVD), renal failure and blindness. As rates of T2DM rise, the need for effective dietary and other lifestyle changes to improve diabetes management become more urgent. Low-glycaemic index (GI) diets may improve glycaemic control in diabetes in the short term; however, there is a lack of evidence on the long-term adherence to low-GI diets, as we ...[more]

PMID: 27388364

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Project description:ObjectiveTo inform the update of the European Association for the Study of Diabetes clinical practice guidelines for nutrition therapy.DesignSystematic review and meta-analysis of randomised controlled trials.Data sourcesMedline, Embase, and the Cochrane Library searched up to 13 May 2021.Eligibility criteria for selecting studiesRandomised controlled trials of three or more weeks investigating the effect of diets with low glycaemic index (GI)/glycaemic load (GL) in diabetes.Outcome and measuresThe primary outcome was glycated haemoglobin (HbA1c). Secondary outcomes included other markers of glycaemic control (fasting glucose, fasting insulin); blood lipids (low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), non-HDL-C, apo B, triglycerides); adiposity (body weight, BMI (body mass index), waist circumference), blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)), and inflammation (C reactive protein (CRP)).Data extraction and synthesisTwo independent reviewers extracted data and assessed risk of bias. Data were pooled by random effects models. GRADE (grading of recommendations assessment, development, and evaluation) was used to assess the certainty of evidence.Results29 trial comparisons were identified in 1617 participants with type 1 and 2 diabetes who were predominantly middle aged, overweight, or obese with moderately controlled type 2 diabetes treated by hyperglycaemia drugs or insulin. Low GI/GL dietary patterns reduced HbA1c in comparison with higher GI/GL control diets (mean difference −0.31% (95% confidence interval −0.42 to −0.19%), P<0.001; substantial heterogeneity, I2=75%, P<0.001). Reductions occurred also in fasting glucose, LDL-C, non-HDL-C, apo B, triglycerides, body weight, BMI, systolic blood pressure (dose-response), and CRP (P<0.05), but not blood insulin, HDL-C, waist circumference, or diastolic blood pressure. A positive dose-response gradient was seen for the difference in GL and HbA1c and for absolute dietary GI and SBP (P<0.05). The certainty of evidence was high for the reduction in HbA1c and moderate for most secondary outcomes, with downgrades due mainly to imprecision.ConclusionsThis synthesis suggests that low GI/GL dietary patterns result in small important improvements in established targets of glycaemic control, blood lipids, adiposity, blood pressure, and inflammation beyond concurrent treatment with hyperglycaemia drugs or insulin, predominantly in adults with moderately controlled type 1 and type 2 diabetes. The available evidence provides a good indication of the likely benefit in this population.Study registrationClinicalTrials.gov NCT04045938.

Project description:ObjectiveTo determine whether psychological interventions have any effect on glycaemic control in people with type 1 diabetes.DesignSystematic review and meta-analysis of psychological therapies to assess their effectiveness in improving glycaemic control in type 1 diabetes.Data sourcesMedline, PsycINFO, Embase, and Cochrane central register of controlled trials searched to September 2004.Review methodsAll included studies were randomised controlled trials in children (including adolescents) or adults with type 1 diabetes that evaluated the effect of a psychological therapy (counselling, cognitive behaviour therapy, family systems therapy, and psychodynamic therapy) on control of diabetes. Data were extracted on sample size, age, duration of diabetes, type of psychological therapy, its mode of delivery, and type of intervention in control group.Main outcome measuresGlycaemic control measured by percentage of glycated haemoglobin and psychological distress. Pooled standardised effect sizes were calculated.Results29 trials were eligible for the systematic review and 21 trials for the meta-analysis. In the 10 studies of children and adolescents included in the meta-analysis, the mean percentage of glycated haemoglobin was significantly reduced in those who had received a psychological intervention compared with those in the control group (pooled standardised mean difference -0.35 (95% confidence interval -0.66 to -0.04), equivalent to a 0.48% (0.05% to 0.91%) absolute reduction in glycated haemoglobin. In the 11 studies in adults the pooled standardised mean difference was -0.17 (-0.45 to 0.10), equivalent to 0.22% (-0.13% to 0.56%) absolute reduction in glycated haemoglobin. Psychological distress was significantly lower in the intervention groups in children and adolescents (pooled standardised effect size -0.46, -0.83 to -0.10) but not in adults (-0.25, -0.51 to 0.01).ConclusionPsychological treatments can slightly improve glycaemic control in children and adolescents with diabetes but have no effect in adults.

Project description:BackgroundIn high-resource settings, structured diabetes self-management education is associated with improved outcomes but the evidence from low-resource settings is limited and inconclusive.AimTo compare, structured diabetes self-management education to usual care, in adults with type 2 diabetes, in low-resource settings.Research design and methodsDesignSingle-blind randomised parallel comparator controlled multi-centre trial. Adults (> 18 years) with type 2 diabetes from two hospitals in urban Ghana were randomised 1:1 to usual care only, or usual care plus a structured diabetes self-management education program. Randomisation codes were computer-generated, and allotment concealed in opaque numbered envelopes. The intervention effect was assessed with linear mixed models.Main outcomeChange in HbA1c after 3-month follow-up. Primary analysis involved all participants.Clinicaltrialgov identifier:NCT04780425, retrospectively registered on 03/03/2021.ResultsRecruitment: 22nd until 29th January 2021. We randomised 206 participants (69% female, median age 58 years [IQR: 49-64], baseline HbA1c median 64 mmol/mol [IQR: 45-88 mmol/mol],7.9%[IQR: 6.4-10.2]). Primary outcome data was available for 79 and 80 participants in the intervention and control groups, respectively. Reasons for loss to follow-up were death (n = 1), stroke(n = 1) and unreachable or unavailable (n = 47). A reduction in HbA1c was found in both groups; -9 mmol/mol [95% CI: -13 to -5 mmol/mol], -0·9% [95% CI: -1·2% to -0·51%] in the intervention group and -3 mmol/mol [95% CI -6 to 1 mmol/mol], -0·3% [95% CI: -0·6% to 0.0%] in the control group. The intervention effect was 1 mmol/mol [95%CI:-5 TO 8 p = 0.726]; 0.1% [95% CI: -0.5, 0.7], p = 0·724], adjusted for site, age, and duration of diabetes. No significant harms were observed.ConclusionIn low-resource settings, diabetes self-management education might not be associated with glycaemic control. Clinician's expectations from diabetes self-management education must therefore be guarded.

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Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial.

Publications

Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial.

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