Diabetes Mellitus Obesity Insulin resistance
Conditions
Interventions
Topiramate:
first week 25 mg od (evening)
second week 25 mg bid
third and fourth week 25 mg od (morning) + 50 mg od (evening)
Sponsors
TI pharma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female volunteers 2. Age > 18 years and 27 kg/m2 and < 44 kg/m2 4. Fasting serum glucose (FSG) 6.1-7 mmol/L
Exclusion criteria
Exclusion criteria: 1. FSG >7 mmol/L 2. Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past. 3. Any significant chronic disease 4. Any significant abnormal laboratory results found during the medical screening procedure 5. Renal, hepatic or endocrine disease (including DM) 6. Use of medication known to influence glucose and/or FFA metabolism 7. Premenopausal women who do not use oral contraceptives or intrauterine device (IUD) 8. Recent weight changes or attempts to loose weight (> 3 kg weight gain or loss, within the last 3 months) 9. Difficulties to insert an intravenous catheter 10. Smoking 11. Severe claustrophobia (ventilated hood) 12. Recent blood donation (within the last 3 months) 13. Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Glucose metabolism: Endogenous glucose production, Ra and Rd of glucose by infusion of [6,6-2H2]glucose two-step hyperinsulinaemic euglycaemic clamp • ß-cell sensitivity: Early and late response of insulin secretion (hyperglycemic clamp) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Anthropometric: Weight, height, waist and hip circumference, Bioelectrical impedance analysis • Lipid metabolism: Ra glycerol by infusion of [2H5]glycerol Indirect calorimetry:resting energy expenditure and RQ, glucose and lipid oxidation rates • Plasma concentrations: Total cholesterol, HDL-C, LDL-C, Triglycerides, Glucose, insulin, glucagon, free fatty acid, • Actimety: Resting energy expenditure, diet induced thermogenesis, active energy expenditure and total energy expenditure. • Diary: Calorie intake, Physical activity | — |
Contacts
Public ContactM. Snel
LUMC, afdeling AIG (C4-70)
Outcome results
None listed