Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

Inclusion Criteria:

• Diagnosis of Metabolic Syndrome
• BMI >/=30kg/m2

• and 3 of the 5 following criteria:

  1. Triglycerides >/=150mg/dl
  2. HDL cholesterol </=40mg/dl (men) or </=50mg/dl (women)
  3. Blood pressure > 130/85
  4. Waist circumference >/=40inches (men) or >/=35inches (women)
  5. 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
• Hypertension must be well controlled for the past 3 months and BP <140/90
• Willing and able to take oral medication
• Female subjects must be post menopausal for 1 year, surgically sterile, or practicing an effective method of birth control; and have a negative monthly pregnancy test at screening and throughout the study.

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.