A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome X
- Sponsor
- Northeastern Ohio Universities College of Medicine
- Enrollment
- 90
- Locations
- 5
- Primary Endpoint
- Change in weight on days 28, 56, 84, 112, 140, 168, and 175.
- Status
- Suspended
- Last Updated
- 18 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Metabolic Syndrome
- •BMI \>/=30kg/m2
- •and 3 of the 5 following criteria:
- •Triglycerides \>/=150mg/dl
- •HDL cholesterol \</=40mg/dl (men) or \</=50mg/dl (women)
- •Blood pressure \> 130/85
- •Waist circumference \>/=40inches (men) or \>/=35inches (women)
- •Fasting blood glucose \>/=110mg/dl or diagnosis of type 2 diabetes mellitus
- •Able to give informed consent
- •Diabetes Mellitus must be well controlled for the past 3 months and HbA1c \</=9.0
Exclusion Criteria
- •Any person unable to take topiramate
- •Renal insufficiency
- •Taking medication with known serious interactions with topiramate
- •History of psychosis, epilepsy or any other disease in which taking topiramate may interfere with treatment of that disease
- •Positive urine drug screen
- •Previous treatment with topiramate and subsequent adverse event; or concurrent treatment with topiramate
- •History of nephrolithiasis
- •Pregnancy or lactating
- •Subjects who are members of the same household
- •Currently on an exercise or diet plan
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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.