Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial

Abstract

BackgroundType 2 diabetes mellitus (T2DM) and obesity are syndemic and will have a significant impact on affected individuals and healthcare services worldwide. Evidence shows that T2DM remission can be achieved with significant weight loss in those who are younger with early diabetes and requiring fewer medications for glycaemic control. DIADEM-I aims to examine the impact of an intensive lifestyle intervention (ILI) using a low-energy diet (LED) meal replacement approach combined with physical activity in younger individuals with early T2DM.MethodsThe planned study is an ongoing, non-blinded, pragmatic, randomised controlled, parallel-group trial examining the impact of an LED-based ILI on body weight and diabetes remission in younger (18–50 years) T2DM individuals with early diabetes (≤ 3-year duration). The ILI will be compared to usual medical care (UMC). The primary outcome will be weight loss at 12 months. Other key outcomes of interest include diabetes remission, glycaemic control, diabetes complications, cardiovascular health, physical activity, mental health, and quality of life. It is planned for the study to include 138 subjects for assessment of the primary outcome. Safety will be assessed throughout.DiscussionIf DIADEM-I demonstrates a clinically significant effect for younger individuals with early T2DM, it will inform clinical guidelines and services of the future for management of T2DM.Trial registrationISRCTN: ISRCTN20754766 (date assigned: 7 June 2017); ClinicalTrials.gov, ID: NCT03225339 Registered on 26 June 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2660-1) contains supplementary material, which is available to authorized users.

A systematic review of randomized controlled trials of dietary interventions for weight loss in adults in the Middle East and north Africa region

“…Also, multidisciplinary approaches with structured interventions combining dietary interventions with exercise and/or behavioural support were rarely used. The results of RCTs using multidisciplinary approaches and evidence based clinical expertise will provide key information about the applicability and acceptability of lifestyle interventions for weight loss in this region 42 …”

Effect of Calorie Restriction and Exercise on Type 2 Diabetes

“…T2D and excess adiposity are linked with one another. Recent evidence shows that weight reduction through medical interventions or bariatric surgery can cause remission in T2D in young people and in those with recent onset of disease [78]. The Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIA-DEM-I) study is a current, non-blinded, pragmatic, randomized, controlled, parallel-group trial.…”

“…The Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIA-DEM-I) study is a current, non-blinded, pragmatic, randomized, controlled, parallel-group trial. It includes 138 subjects, younger adults with T2D, in the early stage of diabetes (≤ 3 year duration) who have undergone intensive lifestyle intervention changes (i.e., 800 kcal/day intake and 150 min/week exercise for 12 weeks) and results are hoped to identify a path to reversal of T2D [78]. Recent evidence has also reported that low-calorie diet and lifestyle interventions resulted in a significant improvement and T2D remission [79].…”

Qatar Diabetes Mobile Application Trial (QDMAT): An Open-Label Randomised Controlled Trial To Examine The Impact of Using A Mobile Application To Improve Diabetes Care In Type 2 Diabetes Mellitus – A Study Protocol

“…The sample size is based on a clinically relevant difference in HbA1c of 0.5% (5.5mmol/mol) SD 1% (11mmol/mol) between the intervention and the standard care arms (25). To achieve an 80% power and a signi cance level of <0.05, 64 participants are required in each arm.…”