PRESERVE TRIAL:Pancreatic beta-cell dysfunction REStorEd by Rosiglitazone and Valsartan Effects. A 52-week randomized controlled factorial study in subjects with IFG and/or IGT.Amendment 2007: PancREatic beta-cell dySfunction rEstoRed by Valsartan Effects – PRESERVE Study.Amendment 2007: In stead of two medicaments (Rosiglitazon and valsartan), only valsartan has been completed. Due to negative publicity, Rosiglitazon was stopped. Target number of participant is thereby decreased from 144
Completed
- Conditions
- Type 2 diabetes mellitus, impaired glucose metabolism
- Registration Number
- NL-OMON23620
- Lead Sponsor
- VU University Medical Center,AmsterdamThe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Male and female subjects (aged 35-70 years) with impaired fasting glucose (IFG; fasting plasma glucose 6.1 or higher and less than 7.0 mmol/l) and/or subjects with IFG (fasting plasma glucose 5.6 or higher and less than 7.0 mmol/l) ánd a family history of DM2 (i.e. first and second degree (i.e. grandparents) relatives), and/or impaired glucose tolerance (IGT; 2-h plasma glucose during 75-g oral glucose tolerance test 7.8-11.1 mmol/l) are eligible.
Exclusion Criteria
Drug use:
1. Current use of ACE-I, ARB and/or TZDs and inability to discontinue these drugs;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare beta-cell function, as reflected by the first phase insulin secretion corrected for insulin sensitivity and/or the arginine-stimulated insulin secretion, both co-primary endpoints as measured during the eu-hyperglycemic clamp procedure, following 52 weeks of rosiglitazone, valsartan or rosiglitazone combined with valsartan in subjects with IFG (with and without a family history of DM2) and/or IGT.<br><br /><br /><br><u>Amendment 2007:</u><br /><br>To compare beta-cell function, as reflected by the first phase insulin secretion corrected for insulin sensitivity and/or the arginine-stimulated insulin secretion, both co-primary endpoints as measured during the eu-hyperglycemic clamp procedure, following 26 weeks of valsartan in subjects with IFG (with and without a family history of DM2) and/or IGT
- Secondary Outcome Measures
Name Time Method