The impact of Rimonabant in overweight women with prior gestational diabetes - RIGD
- Conditions
- Rimonabant has been shown to reduce body weight and improve cardiovascular risk factors and metabolic control. Therefore we investigate in women with previous gestational diabetes and impaired glucose tolerance at the postpartum reclassification the impact of Rimonabant on plasma lipids, abdominal obesity, body weight and glucose tolerance (insulin sensitivity).MedDRA version: 9.1Level: LLTClassification code 10033307Term: OverweightMedDRA version: 9.1Level: LLTClassification code 10058110Term: DyslipidemiaMedDRA version: 9.1Level: LLTClassification code 10051361Term: AdipositasMedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2007-000907-13-AT
- Lead Sponsor
- MUW, Innere Med III, Abt.für Endokrinologie & Stoffwechsel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
-Age: 20-50 years
-Prior gestational diabetes
-BMI: BMI > 30 kg/m² OR BMI > 27 kg/m² if dyslipidemia or diabetes/pre-diabetes are present.
-Metabolism: prediabetes (IFG: fasting glucose > 100 mg/dl , but < 126 mg/dl AND/OR IGT: 2h glucose/oGTT > 140 mg/dl, but < 200 mg/dl) or diabetes (Fasting glucose > 126 mg/dl; 2h glucose/oGTT > 200 mg/dl)
(WHO criteria)
-Lipids: HDL cholesterol < 50 mg/dl or triglycerides > 150 mg/dl
-Metabolic syndrome (WHO criteria)
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) no
F.1.3.1 Number of subjects for this age range
-Kidney or liver disease
-Any chronic disease
-Acute or chronic inflammatory disease
-Psychiatric disorder (Depressio!)
-Lactation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method