Investigating the limits of reversibility of type 2 diabetes
Completed
- Conditions
- Diabetic Control, Nutrition, ObesityNutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitus
- Registration Number
- ISRCTN88634530
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
1. Type 2 diabetes of < 4 years or > 8 years duration
2. HbA1c < 80 mmol/l / 9.5%
3. BMI 28-40kg/m2
4. Age 25-80 years
5. Stable weight for previous 6 months (within 5kg)
6. Male and female participants
Exclusion Criteria
1. Current treatment with thiazolidinediones, GLP-1 agonists or steroids
2. Renal or hepatic dysfunction
3. Contraindications to MRI
4. Alcohol consumption > 3 units per day for women and > 4 units per day for men
5. Allergy to soybean or eggs
6. Highly restrictive diet
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Restated primary outcome measures as of 31/07/2015:<br>Fasting plasma glucose at 6 months in the group achieving non-diabetic levels at 10 weeks (following VLCD and return to normal eating)<br><br>Previous primary outcome measures:<br>Beta cell function measured at baseline, 8 weeks and 8 months
- Secondary Outcome Measures
Name Time Method Added 31/07/2015:<br>Change in beta cell function from 10 weeks to 6 months