Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

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
• •Bariatric surgery within the past 5 years
• •Clinically significant medical conditions including (but not limited to) symptomatic coronary artery disease or peripheral vascular disease, or taking nitrates; malignancy or history of malignancy within the past 5 years (except basal cell carcinoma); Impaired renal function as defined by an estimated creatinine clearance \</=60ml/min; Gastrointestinal system diseases including active liver disease; ALT or AST\>2 times the upper limit of normal; Pulmonary disorders; Endocrine disorders except for well controlled diabetes mellitus and hypothyroidism; Any disease or condition that compromises the function of those body systems that could result in altered absorption, excess accumulation, or impaired metabolism or excretion of topiramate.
• •Subjects who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings, or contraindications sections of the topiramate package insert
• •Family members of employees or investigators and employees of the investigator or study center may participate but may not serve any staff role for themselves.