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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31914

Enrollment

Registered

2008-02-21

Start date

2008-03-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesitas metabolic syndrome obesity

Interventions

4 weeks Topiramate (first week 25 mg od (evening)

second week 25 mg bid

third and fourth week 25 mg od (morning) + 50 mg od (evening)) and 4 weeks Placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Female volunteers Age > 18 years and 27 kg/m2 and

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
•Anthropometric: Weight, height, waist and hip circumference, Bioelectrical impedance analysis •Glucose metabolism: Endogenous glucose production, Ra and Rd of glucose by infusion of [6,6-2H2]glucose two-step hyperinsulinaemic euglycaemic clamp •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, total glycerol, Isotope enrichment of [6,6-2H2]glucose and [2H5]glycerol, lactate, cortisol, Growth Hormone •ß-cell sensitivity: Early and late response of insulin secretion (hyperglycemic clamp) •Actimety: Resting energy expenditure, diet induced thermogenesis, active energy expenditure and total energy expenditure. •Diary: Calorie intake, Physical activity	—

Measure

Time frame

•Anthropometric: Weight, height, waist and hip circumference, Bioelectrical impedance analysis •Glucose metabolism: Endogenous glucose production, Ra and Rd of glucose by infusion of [6,6-2H2]glucose two-step hyperinsulinaemic euglycaemic clamp •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, total glycerol, Isotope enrichment of [6,6-2H2]glucose and [2H5]glycerol, lactate, cortisol, Growth Hormone •ß-cell sensitivity: Early and late response of insulin secretion (hyperglycemic clamp) •Actimety: Resting energy expenditure, diet induced thermogenesis, active energy expenditure and total energy expenditure. •Diary: Calorie intake, Physical activity

—

Secondary

Measure	Time frame
none	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)