The effect of short term Topiramate treatment on insulin secretion, glucose- and lipid metabolism in obese wome

Phase 4

Conditions: obesitas
metabolic syndrome
10018424
obesity

Registration Number: NL-OMON31914

Lead Sponsor: Top Institute Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 13

Inclusion Criteria

Female volunteers
Age > 18 years and < 70 years
BMI > 27 kg/m2 and < 44 kg/m2
Fasting serum glucose (FSG) 6.1-7 mmol/L

Exclusion Criteria

FSG >7 mmol/L
Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past.
Any significant chronic disease
Any significant abnormal laboratory results found during the medical screening procedure
Renal, hepatic or endocrine disease (including DM)
Use of medication known to influence glucose and/or FFA metabolism
Premenopausal women who do not use oral contraceptives or intrauterine device
Recent weight changes or attempts to loose weight (> 3 kg weight gain or loss, within the last 3 months)
Difficulties to insert an intravenous catheter
Smoking
Severe claustrophobia (ventilated hood)
Recent blood donation (within the last 3 months)
Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>•Anthropometric: Weight, height, waist and hip circumference, Bioelectrical<br /><br>impedance analysis<br /><br>•Glucose metabolism: Endogenous glucose production, Ra and Rd of glucose by<br /><br>infusion of [6,6-2H2]glucose two-step hyperinsulinaemic euglycaemic clamp<br /><br>•Lipid metabolism: Ra glycerol by infusion of [2H5]glycerol<br /><br>•Indirect calorimetry: resting energy expenditure and RQ, glucose and lipid<br /><br>oxidation rates<br /><br>•Plasma concentrations: Total cholesterol, HDL-C, LDL-C, Triglycerides,<br /><br>Glucose, insulin, glucagon, free fatty acid, total glycerol, Isotope enrichment<br /><br>of [6,6-2H2]glucose and [2H5]glycerol, lactate, cortisol, Growth Hormone<br /><br>•ß-cell sensitivity: Early and late response of insulin secretion<br /><br>(hyperglycemic clamp)<br /><br>•Actimety: Resting energy expenditure, diet induced thermogenesis, active<br /><br>energy expenditure and total energy expenditure.<br /><br>•Diary: Calorie intake, Physical activity</p><br>

Secondary Outcome Measures