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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Akron General Medical Center
Akron, Ohio, United States
Mercy Medical Center
Canton, Ohio, United States
Aultman Hospital
Canton, Ohio, United States
Forum Health/Northside Medical Center
Youngstown, Ohio, United States
Change in weight on days 28, 56, 84, 112, 140, 168, and 175.
Waist circumference on days 1, 84 and 168.
BMI on days 1, 84, 168, and 175.
Blood pressure on days 1, 28, 56, 84, 112, 140, 168, and 175.
Complete metabolic profile on days 84 and 168.
HbA1C on days 1, 84, and 168.
Lipid profile on days 84 and 168.
C reactive protein on days 1, 84, and 168.
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St. Elizabeth Health Center
Youngstown, Ohio, United States