Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

Diabetes Mellitus, Type 2 Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Metabolic Syndrome X
• Syndrome
• Weight Loss

• NCT number: NCT00243984
• Study type: Interventional
• Source: Northeastern Ohio Universities College of Medicine
• Status: Suspended
• Phase: Phase 3
• Start date: March 2005
• Completion date: November 2007