An intervention examining the effect of an intensive lifestyle intervention consisting of a low energy diet and physical activity on weight loss in subjects with early type 2 diabetes.

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN20754766
• Lead Sponsor: Weill Cornell Medicine in Qatar

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-07
• Study Completion: 2020-12-31
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight is measured using Tanita scales at baseline, 3 months, 6 months, 9 months, and 12 months.