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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: Overweight
MedDRA version: 9.1Level: LLTClassification code 10058110Term: Dyslipidemia
MedDRA version: 9.1Level: LLTClassification code 10051361Term: Adipositas
MedDRA 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
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 < 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

Exclusion Criteria

-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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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