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