PRESERVE TRIAL: Pancreatic beta-cell dysfunction REStorEd by Rosiglitazone and Valsartan Effects; A 52-week randomized controlled factorial study in subjects with impaired fasting glucose and/or impaired glucose tolerance - PRESERVE

• Conditions: subjects with impaired fasting glucose (IFG; blood glucose > or = 5.6 and < 7 mmol/l) and/or impaired glucose tolerance (IGT; 2-h post-load glucose 7.8-11.1 mmol/l).; MedDRA version: 8.1Level: LLTClassification code 10018429Term: Glucose tolerance impaired

• Registration Number: EUCTR2006-003483-59-NL
• Lead Sponsor: VU University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

One-hundred and forty-four male and female subjects (aged 35-70 years) with impaired fasting glucose (IFG; plasma glucose > or = 6.1 and < 7.0 mmol/l) and/or subjects with IFG (plasma glucose > or = 5.6 and < 7.0 mmol/l) and a family history of DM2 (i.e. first and second degree (i.e. grandparents) relatives), and/or impaired glucose tolerance (2-h plasma glucose during 75-g OGTT 7.8-11.1 mmol/l) are eligible.
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

Drug use: current use of ACE-i, ARB and/or TZD's, inability to discontinue these medications; Known hypersensitivity to the study drugs; prior use of blood glucose lowering medications; use of systemic glucocorticoids.
Cardiovascular Disease: uncontrolled hypertension requiring ACE-i or ARB; ejection fraction known to be <40% or congestive heart failure, or existing clinical cardiovascular disease.
Other criteria: history of DM (except gestational DM); renal or hepatic disease; major illness with life expectancy <5 years; use of other experimental drugs; pregnant; disease/ medications that affect glucose tolerance; unwillingness to be randomized or sign informed consent; known uncontrolled substance abuse; inability to understand study information and/or communicate with clinical staff.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified