Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

December 7, 2007 updated by: Northeastern Ohio Universities College of Medicine

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northeastern Ohio Universities College of Medicine

Collaborators

Mercy Medical Center
Aultman Health Foundation
Akron General Medical Center
Forum Health
St. Elizabeth Health Center

Investigators

  • Principal Investigator: Frederick Whittier, MD, Northeastern Ohio Universities College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (ANTICIPATED)

November 1, 2007

Study Registration Dates

First Submitted

October 21, 2005

First Submitted That Met QC Criteria

October 21, 2005

First Posted (ESTIMATE)

October 25, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2007

Last Update Submitted That Met QC Criteria

December 7, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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