The effect of metformin on weight and cardiovascular risk markers in abdomenally obese subjects with impaired fasting glucose previously treated for 12 months with either rimonabant or placebo - Use of Metformin following weight loss and improvement in CV risk
Phase 1
- Conditions
- Impaired fasting glucoseMedDRA version: 9.1Level: LLTClassification code 10056997Term: Impaired fasting glucose
- Registration Number
- EUCTR2008-004497-40-GB
- Lead Sponsor
- Hull and East Yorkshire Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
Previous participation in RIMON_R_00961
Impaired fasting glucose
LFT less than 200% reference range
Serum Creatinine less than 150 mmol/l
Willing to allow GP to be informed
Able to give consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not having previously been diagnosed with diabetes
Previously been treated with antidiabetes medication
Not able to give consent or allow GP to be informed
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does metformin reduce weight regain and reduce the risk of developing diabetes and heart disease in subjects with impaired fasting glucose who have previously been treated for weight loss with lifestyle advice and rimonabant/placebo?;Secondary Objective: Does metformin have a greater effect in subjects previously treated with rimonabant when compared to placebo?<br>Is treatment with metformin following rimonabant more clinically and cost effective than treating with rimonabant alone?;Primary end point(s): Weight, no weight gain over 12 months<br>Reduced insulin resistance<br>Improved lipid profile
- Secondary Outcome Measures
Name Time Method