Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial assessing the impact of low energy diet and activity on body weight and glycaemia in diabetes

Weill Cornell Medicine in Qatar0 个研究点目标入组 158 人开始时间: 2017年6月7日最近更新: 2023年7月25日

适应症

试验速览

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29784059 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32445735/ results (added 25/05/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33293319/ Recruitment and baseline characteristics (added 11/07/2023)

•1. Type 2 diabetes mellitus
•2. Diabetes of = 3-year duration
•3. BMI =27.0 kg/m²
•4. Men and women
•5. Age 18-50 years
•6. Originating from the Middle East and North Africa region and resident in Qatar
•7. Able to commit to the study duration
•8. Able to give informed consent and willing to participate in the study

•1. Type 1 diabetes mellitus based on clinical history
•2. Cardiovascular event in the previous 6 months
•3. Chronic kidney disease stage 3b or greater (eGFR <30 mL/min/1.73 m²)
•4. Currently pregnant, lactating, or planning pregnancy within the study period
•5. Any condition precipitating fluid overload such as heart failure (NYHA class > I) and liver cirrhosis
•6. Significant previously diagnosed psychiatric disorder (e.g. schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder)
•7. Uncontrolled depression
•8. Uncontrolled epilepsy
•9. Known lactose intolerance
•10. Severe arthritis preventing walking
•11. Active gout
•12. Active gallstone disease or known asymptomatic gallstones

发起方

Weill Cornell Medicine in Qatar