Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

Northeastern Ohio Universities College of Medicine

Status and phase

Suspended

Phase 3

Conditions

Metabolic Syndrome X

Diabetes Mellitus, Type 2

Treatments

Drug: topiramate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00243984

05005

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.