The effect of short term Topiramate treatment on insulin secretion, glucose and lipid metabolism in obese wome
- Conditions
- Diabetes MellitusObesityInsulin resistance
- Registration Number
- NL-OMON28677
- Lead Sponsor
- TI pharma
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 13
Inclusion Criteria
1. Female volunteers
2. Age > 18 years and < 70 years
Exclusion Criteria
1. FSG >7 mmol/L
2. Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Glucose metabolism:<br /><br>Endogenous glucose production, Ra and Rd of glucose<br>by infusion of [6,6-2H2]glucose two-step hyperinsulinaemic euglycaemic clamp<br /><br>• ß-cell sensitivity:<br /> Early and late response of insulin secretion<br>(hyperglycemic clamp)
- Secondary Outcome Measures
Name Time Method • Anthropometric:<br /><br>Weight, height, waist and hip circumference, <br>Bioelectrical impedance analysis<br /><br>• Lipid metabolism:<br /><br>Ra glycerol by infusion of [2H5]glycerol<br>Indirect calorimetry:resting energy expenditure and RQ, glucose and lipid<br>oxidation rates <br /><br>• Plasma concentrations:<br /><br>Total cholesterol, HDL-C, LDL-C, Triglycerides,<br>Glucose, insulin, glucagon, free fatty acid, <br /><br>• Actimety:<br /><br>Resting energy expenditure, diet induced <br>thermogenesis, active energy expenditure and total energy expenditure.<br /><br>• Diary:<br /><br>Calorie intake, Physical activity<br> <br>