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.
Highlights
Type 2 diabetes mellitus (T2DM) and obesity are syndemic and will have a significant impact on affected individuals and healthcare services worldwide
Obesity is associated with multiple complications including T2DM, hypertension, dyslipidaemia, non-alcoholic fatty liver disease (NAFLD), obstructive sleep apnoea (OSA), cardiovascular disease (CVD), chronic kidney disease (CKD), increased risk for several cancers, poor mental health, and reduced quality of life [1,2,3,4,5,6,7,8]
Current evidence suggests that weight loss through medical interventions or bariatric surgery can result in diabetes remission
Summary
Type 2 diabetes mellitus (T2DM) and obesity are syndemic and will have a significant impact on affected individuals and healthcare services worldwide. Obesity and type 2 diabetes mellitus (T2DM) are the greatest challenges to health services worldwide. The onset of obesity at a young age results in significant morbidity and mortality [9,10,11,12]. In a cohort of young men (n = 6502, age 22 years) followed up in Denmark, 48% of those who were obese (Body Mass Index, BMI ≥ 30 kg/m2) had developed diabetes, cardiovascular disease, or venous thromboembolism, or had died before the age of 55 years [13]. In a cohort of healthy young men (n = 37,674), there was an independent association between elevated BMI at age 17 years and angiography-proven coronary heart disease (β = 1.355, P = 0.004) [12]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
