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: 9.1 Level: LLT Classification code 10033307 Term: Overweight MedDRA version: 9.1 Level: LLT Classification code 1005
Conditions
Interventions
Trade Name: Acomplia
Product Name: Rimonabant
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
MUW, Innere Med III, Abt.für Endokrinologie & Stoffwechsel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 140 mg/dl, but 126 mg/dl; 2h glucose/oGTT > 200 mg/dl) (WHO criteria) - Lipids: HDL cholesterol 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
Exclusion criteria
Exclusion criteria: - Kidney or liver disease - Any chronic disease - Acute or chronic inflammatory disease - Psychiatric disorder (Depressio!) - Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): Plasma lipids (plasma Free Fatty Acids, triglycerides and cholesterol) OGTT: glucose tolerance, insulin and proinsulin secretion FSIGT: insulin sensitivity (SI), acute insulin response (AIRg), disposition index Adipocytokines: Visfatin, adiponectin, retinol binding protein 4, leptin, PAI-1, Ghrelin, us CRP BMI ;Main Objective: Aim of this study is to test the hypothesis that drug therapy with Rimonabant (20 mg/day) for 6 months in overweight women with prior gestational diabetes and impaired glucose tolerance at the postpartum reclassification will i) improve dyslipidemia, insulin sensitivity, beta cell-function and ii) reduce abdominal obesity or body weight and thus iii) convert glucose tolerance or iiii) reduce risk for progression to diabetes and iiiii) will also improve the cardiovascular risk profile compared to age and BMI matched women with prior gestational diabetes but without drug therapy. | — |
Countries
Austria
Outcome results
None listed