Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial

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Shahrad Taheri 1, Hadeel Zaghloul 2, Odette Chagoury 3, Sara Elhadad 3, Salma Hayder Ahmed 3, Neda El Khatib 4, Rasha Abou Amona 4, Katie El Nahas 4, Noor Suleiman 5, Abdulla Alnaama 6, Abdulla Al-Hamaq 4, Mary Charlson 7, Martin T Wells 8, Samya Al-Abdulla 6, Abdul Badi Abou-Samra 5

Main idea: These findings show that the intensive lifestyle intervention led to significant weight loss at 12 months, and was associated with diabetes remission in over 60% of participants and normoglycaemia in over 30% of participants. The provision of this lifestyle intervention could allow a large proportion of young individuals with early diabetes to achieve improvements in key cardiometabolic outcomes, with potential long-term benefits for health and wellbeing.

Abstract

Background: Type 2 diabetes is affecting people at an increasingly younger age, particularly in the Middle East and in north Africa. We aimed to assess whether an intensive lifestyle intervention would lead to significant weight loss and improved glycaemia in young individuals with early diabetes.

Methods: DIADEM-I is an open-label, parallel-group, randomised controlled trial done in Qatar. It compared the effects of an intensive lifestyle intervention with usual medical care on weight loss and glycaemic outcomes in people with type 2 diabetes. The primary outcome was weight loss at 12 months after receiving the intervention. Key secondary outcomes included diabetes control and remission. The trial was registered with the ISRCTN registry, ISR CTN20754766, and ClinicalTrials.gov, NCT03225339. .

Findings: In the intervention group, 21% of participants achieved more than 15% weight loss between baseline and 12 months compared with just 1% of those in the control group. Diabetes remission occurred in 61% of Participants in the Intervention group compared with 12% in the Control Group. Five serious adverse events were reported in four participants in the control group. Four admissions to hospital because of unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis) and one admission to hospital for an anticipated event (hyperglycaemia) The study enrolled 158 participants (n=79 in each group) between July 16, 2017, and Sept 30, 2018.

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