Content area
Background
Type 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.
Methods
The 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.
Discussion
If 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 registration
ISRCTN: ISRCTN20754766 (date assigned: 7 June 2017); ClinicalTrials.gov, ID: NCT03225339 Registered on 26 June 2017.
Details
Diabetes;
Physical fitness;
Body mass index;
Mortality;
Intervention;
Diet;
Remission (Medicine);
Energy;
Metabolism;
Insulin;
Aerobics;
Gastrointestinal surgery;
Age;
Weight control;
Liver;
Blood pressure;
Hypertension;
Obesity;
Cardiovascular disease;
Primary care;
Strength training;
Feasibility studies;
Systematic review;
Lifestyles;
Clinical practice guidelines
; Chagoury, Odette 2 ; Zaghloul, Hadeel 3 ; Elhadad, Sara 4 ; Ahmed, Salma Hayder 4 ; Omar, Omar 4 ; Payra, Sherryl 4 ; Ahmed, Salma 4 ; El Khatib, Neda 5 ; Amona, Rasha Abou 5 ; El Nahas, Katie 5 ; Bolton, Matthew 6 ; Chaar, Henem 6 ; Suleiman, Noor 7 ; Jayyousi, Amin 7 ; Zirie, Mahmoud 7 ; Janahi, Ibrahim 7 ; Elhag, Wahiba 8 ; Alnaama, Abdulla 9 ; Zainel, Abduljaleel 9 ; Hassan, Dahlia 9 ; Cable, Tim 10 ; Charlson, Mary 11 ; Wells, Martin 12 ; Al-Hamaq, Abdulla 5 ; Al-Abdulla, Samya 9 ; Abou-Samra, Abdul Badi 13 1 Department of Medicine, Weill Cornell Medicine – Qatar, Doha, Qatar; Weill Cornell Medicine – New York, Joan and Sanford I. Weill Department of Medicine, New York, USA (GRID:grid.5386.8) (ISNI:000000041936877X); Clinical Research Core, Weill Cornell Medicine – Qatar, Doha, Qatar (GRID:grid.5386.8); Qatar Metabolic Institute (QMI), Department of Medicine, Hamad Medical Corporation, Doha, Qatar (GRID:grid.413548.f) (ISNI:0000 0004 0571 546X); Weill Cornell Medicine – Qatar, Qatar Foundation – Education City, Doha, Qatar (GRID:grid.413548.f)
2 Department of Medicine, Weill Cornell Medicine – Qatar, Doha, Qatar (GRID:grid.413548.f); Weill Cornell Medicine – New York, Joan and Sanford I. Weill Department of Medicine, New York, USA (GRID:grid.5386.8) (ISNI:000000041936877X); Clinical Research Core, Weill Cornell Medicine – Qatar, Doha, Qatar (GRID:grid.5386.8)
3 Department of Medicine, Weill Cornell Medicine – Qatar, Doha, Qatar (GRID:grid.5386.8); Weill Cornell Medicine – New York, Joan and Sanford I. Weill Department of Medicine, New York, USA (GRID:grid.5386.8) (ISNI:000000041936877X); Clinical Research Core, Weill Cornell Medicine – Qatar, Doha, Qatar (GRID:grid.5386.8)
4 Clinical Research Core, Weill Cornell Medicine – Qatar, Doha, Qatar (GRID:grid.5386.8)
5 Qatar Diabetes Association, Qatar Foundation, Doha, Qatar (GRID:grid.418818.c) (ISNI:0000 0001 0516 2170)
6 Clinical Research Core, Weill Cornell Medicine – Qatar, Doha, Qatar (GRID:grid.418818.c)
7 Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar (GRID:grid.413548.f) (ISNI:0000 0004 0571 546X)
8 Qatar Metabolic Institute (QMI), Department of Medicine, Hamad Medical Corporation, Doha, Qatar (GRID:grid.413548.f) (ISNI:0000 0004 0571 546X)
9 Primary Health Care Corporation, Doha, Qatar (GRID:grid.498624.5) (ISNI:0000 0004 4676 5308)
10 Aspire Academy, Doha, Qatar (GRID:grid.417586.9) (ISNI:0000 0004 0421 7725)
11 Weill Cornell Medicine – New York, Joan and Sanford I. Weill Department of Medicine, New York, USA (GRID:grid.5386.8) (ISNI:000000041936877X)
12 Cornell University, Department of Statistical Science, Ithaca, USA (GRID:grid.5386.8) (ISNI:000000041936877X)
13 Department of Medicine, Weill Cornell Medicine – Qatar, Doha, Qatar (GRID:grid.498624.5); Qatar Metabolic Institute (QMI), Department of Medicine, Hamad Medical Corporation, Doha, Qatar (GRID:grid.413548.f) (ISNI:0000 0004 0571 546X); Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar (GRID:grid.413548.f) (ISNI:0000 0004 0571 546X)