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

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

- 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 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.