Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

• Status: Suspended
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northeastern Ohio Universities College of Medicine
• Collaborators: Akron General Medical Center; Aultman Health Foundation; Forum Health; Mercy Medical Center; St. Elizabeth Health Center
• Treatments: Topiramate

Criteria

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 clearanceGastrointestinal 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.