NCT00243984

Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Northeastern Ohio Universities College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of topiramate compared to placebo in the treatment of obesity in metabolic syndrome. Secondary objectives include topiramate and weight loss effects on lipid levels, HbA1C, insulin resistance, and blood pressure.

Detailed description

Topiramate is an anti-convulsant which has been approved for use as adjunctive treatment for partial-onset seizures, Lennox-Gastaut syndrome, or primary generalized tonic-clonic seizures. Topiramate is currently under investigation for other disorders including binge-eating disorder. Metabolic syndrome is a constellation of findings which includes dyslipidemia, abdominal obesity, hyperglycemia, and hypertension. Insulin resistance is believed to be the cause whereby obesity increases resistance to insulin. Weight loss in type 2 diabetics is known to reduce insulin resistance and allow for greater glycemic control. Weight loss in pre-diabetics can often forstall the development of diabetes. Additionally, aggressive blood pressure control in diabetics reduces the risk of coronary artery disease. Weight loss reduces blood pressure and is used as first line treatment for hypertension. Comparison: Patients who meet the criteria for metabolic syndrome and prescribed topiramate will be compared with those patients who meet the same criteria and are prescribed placebo.

Conditions

• Metabolic Syndrome X
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	topiramate

Timeline

• Start date: 2005-03-01
• Completion: 2007-11-01
• First posted: 2005-10-25
• Last updated: 2007-12-10

Locations

5 sites across 1 country: United States