Diabetes Remission Clinical Trial
- Conditions
- Type 2 diabetesNutritional, Metabolic, EndocrineType 2 diabetes mellitus
- Registration Number
- ISRCTN03267836
- Lead Sponsor
- HS Greater Glasgow and Clyde (UK)
- Brief Summary
2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26879684 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29221645 1-year results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29188339 baseline results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30852132 2-year results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34056684/ (added 01/06/2021) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38423026/ 5-year results (added 01/03/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 306
1. Men and women aged 20-65 years, all ethnicities
2. T2DM of duration 0-6 years
3. Body Mass Index (BMI) >27 kg/m2
1. Current insulin use
2. HbA1c =12%
3. Substance abuse
4. Known cancer
5. Myocardial infarction within previous 6 months
6. Learning difficulties
7. Current treatment with anti-obesity drugs
8. Diagnosed eating disorder or purging
9. Pregnant/considering pregnancy
10. Patients who have required hospitalisation for depression or are on antipsychotic drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in weight of 15 kg (assumed equal on average to 15%) or more<br>Co-primary outcome: Reversal of diabetes (HbA1c <6.5%)<br>Both outcomes measured at 1 year
- Secondary Outcome Measures
Name Time Method 1. Quality of life measured by EQ-5D questionnaire<br>2. Physical activity level measured using Sensewear Monitor<br>3. Serum lipids<br>All outcomes measured at 1 year