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
Shahrad Taheri,
Odette Chagoury,
Hadeel Zaghloul,
Sara Elhadad,
Salma Hayder Ahmed,
Omar Omar,
Sherryl Payra,
Salma Ahmed,
Neda El Khatib,
Rasha Abou Amona,
Katie El Nahas,
Matthew Bolton,
Henem Chaar,
Noor Suleiman,
Amin Jayyousi,
Mahmoud Zirie,
Ibrahim Janahi,
Wahiba Elhag,
Abdulla Alnaama,
Abduljaleel Zainel,
Dahlia Hassan,
Tim Cable,
Mary Charlson,
Martin Wells,
Abdulla Al-Hamaq,
Samya Al-Abdulla,
Abdul Badi Abou-Samra
Affiliations
Shahrad Taheri
Department of Medicine, Weill Cornell Medicine – Qatar
Odette Chagoury
Department of Medicine, Weill Cornell Medicine – Qatar
Hadeel Zaghloul
Department of Medicine, Weill Cornell Medicine – Qatar
Sara Elhadad
Clinical Research Core, Weill Cornell Medicine – Qatar
Salma Hayder Ahmed
Clinical Research Core, Weill Cornell Medicine – Qatar
Omar Omar
Clinical Research Core, Weill Cornell Medicine – Qatar
Sherryl Payra
Clinical Research Core, Weill Cornell Medicine – Qatar
Salma Ahmed
Clinical Research Core, Weill Cornell Medicine – Qatar
Neda El Khatib
Qatar Diabetes Association, Qatar Foundation
Rasha Abou Amona
Qatar Diabetes Association, Qatar Foundation
Katie El Nahas
Qatar Diabetes Association, Qatar Foundation
Matthew Bolton
Clinical Research Core, Weill Cornell Medicine – Qatar
Henem Chaar
Clinical Research Core, Weill Cornell Medicine – Qatar
Noor Suleiman
Department of Diabetes and Endocrinology, Hamad Medical Corporation
Amin Jayyousi
Department of Diabetes and Endocrinology, Hamad Medical Corporation
Mahmoud Zirie
Department of Diabetes and Endocrinology, Hamad Medical Corporation
Ibrahim Janahi
Department of Diabetes and Endocrinology, Hamad Medical Corporation
Wahiba Elhag
Qatar Metabolic Institute (QMI), Department of Medicine, Hamad Medical Corporation
Abdulla Alnaama
Primary Health Care Corporation
Abduljaleel Zainel
Primary Health Care Corporation
Dahlia Hassan
Primary Health Care Corporation
Tim Cable
Aspire Academy
Mary Charlson
Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine – New York
Martin Wells
Department of Statistical Science, Cornell University
Abdulla Al-Hamaq
Qatar Diabetes Association, Qatar Foundation
Samya Al-Abdulla
Primary Health Care Corporation
Abdul Badi Abou-Samra
Department of Medicine, Weill Cornell Medicine – Qatar
Abstract 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.
