Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

NCT ID: NCT00243984


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
Purpose
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.
Details
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
Keywords
metabolic syndrome, type 2 diabetes, topiramate, weight loss
Source
Northeastern Ohio Universities College of Medicine
Sponsors
Northeastern Ohio Universities College of Medicine, Akron General Medical Center, Forum Health, Aultman Health Foundation, St. Elizabeth Health Center, Mercy Medical Center
Status
Suspended
Acronym
Last Updated
06 Dec 2007
URL
Official Link
Locations
United States