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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

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Publicado en:Trials vol. 19, no. 1 (Dec 2018), p. 284
Autor principal: Taheri, Shahrad
Otros Autores: Chagoury, Odette, Zaghloul, Hadeel, Elhadad, Sara, Ahmed, Salma Hayder, Omar, Omar, Payra, Sherryl, Ahmed, Salma, El Khatib, Neda, Amona, Rasha Abou, El Nahas, Katie, Bolton, Matthew, Chaar, Henem, Suleiman, Noor, Jayyousi, Amin, Zirie, Mahmoud, Janahi, Ibrahim, Elhag, Wahiba, Alnaama, Abdulla, Zainel, Abduljaleel, Hassan, Dahlia, Cable, Tim, Charlson, Mary, Wells, Martin, Al-Hamaq, Abdulla, Al-Abdulla, Samya, Abou-Samra, Abdul Badi
Publicado:
Springer Nature B.V.
Materias:
United Kingdom > UK
Exercise
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
Acceso en línea:Citation/Abstract
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Resumen: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&#xa0;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&#xa0;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: <ext-link xlink:href="https://doi.org/10.1186/ISRCTN20754766" ext-link-type="url">ISRCTN20754766</ext-link> (date assigned: 7 June 2017); ClinicalTrials.gov, ID: <ext-link xlink:href="https://clinicaltrials.gov/ct2/show/NCT03225339" ext-link-type="url">NCT03225339</ext-link> Registered on 26 June 2017.
ISSN:1745-6215
1468-6708
1468-6694
DOI:10.1186/s13063-018-2660-1
Fuente:Health & Medical Collection