Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

This study has been suspended.

( Study was discontinued because of high drop out rate. )

First Received: October 21, 2005 Last Updated: December 7, 2007 History of Changes

Sponsors and Collaborators:	Northeastern Ohio Universities College of Medicine Akron General Medical Center Forum Health Aultman Health Foundation St. Elizabeth Health Center Mercy Medical Center
Information provided by:	Northeastern Ohio Universities College of Medicine
ClinicalTrials.gov Identifier:	NCT00243984

Purpose

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.

Condition	Intervention	Phase
Metabolic Syndrome X Diabetes Mellitus, Type 2	Drug: topiramate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Metabolic Syndrome Weight Control

Drug Information available for: Topiramate

U.S. FDA Resources

Further study details as provided by Northeastern Ohio Universities College of Medicine:

Primary Outcome Measures:

Change in weight on days 28, 56, 84, 112, 140, 168, and 175.
Waist circumference on days 1, 84 and 168.
BMI on days 1, 84, 168, and 175.

Secondary Outcome Measures:

Blood pressure on days 1, 28, 56, 84, 112, 140, 168, and 175.
Complete metabolic profile on days 84 and 168.
HbA1C on days 1, 84, and 168.
Lipid profile on days 84 and 168.
C reactive protein on days 1, 84, and 168.

Estimated Enrollment:	90
Study Start Date:	March 2005
Estimated Study Completion Date:	November 2007

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243984

Locations

United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
St. Elizabeth Health Center
Youngstown, Ohio, United States, 44501
Forum Health/Northside Medical Center
Youngstown, Ohio, United States, 44501
Mercy Medical Center
Canton, Ohio, United States, 44708
Aultman Hospital
Canton, Ohio, United States, 44710

Sponsors and Collaborators

Northeastern Ohio Universities College of Medicine

Akron General Medical Center

Forum Health

Aultman Health Foundation

St. Elizabeth Health Center

Mercy Medical Center

Investigators

Principal Investigator:

Frederick Whittier, MD

Northeastern Ohio Universities College of Medicine

More Information

No publications provided

Study ID Numbers:	05005
Study First Received:	October 21, 2005
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00243984 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Northeastern Ohio Universities College of Medicine:

metabolic syndrome
type 2 diabetes
topiramate
weight loss

Study placed in the following topic categories:

Metabolic Syndrome X
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Neuroprotective Agents
Abdominal Obesity Metabolic Syndrome
Body Weight
Anti-Obesity Agents
Signs and Symptoms
Hyperinsulinism

Diabetes Mellitus, Type 2
Weight Loss
Body Weight Changes
Topiramate
Endocrinopathy
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Anticonvulsants

Additional relevant MeSH terms:

Metabolic Syndrome X
Metabolic Diseases
Disease
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Body Weight
Anti-Obesity Agents
Hyperinsulinism

Signs and Symptoms
Pathologic Processes
Therapeutic Uses
Syndrome
Diabetes Mellitus, Type 2
Weight Loss
Body Weight Changes
Topiramate
Insulin Resistance
Glucose Metabolism Disorders
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 10, 2009