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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. )

Sponsors and Collaborators: Northeastern Ohio Universities College of Medicine
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

MedlinePlus related topics:   Diabetes    Metabolic Syndrome    Weight Control   

ChemIDplus related topics:   Topiramate   

U.S. FDA Resources

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

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
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


Study ID Numbers:   05005
First Received:   October 21, 2005
Last Updated:   December 7, 2007
ClinicalTrials.gov Identifier:   NCT00243984
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
Body Weight
Signs and Symptoms
Hyperinsulinism
Diabetes Mellitus, Type 2
Weight Loss
Body Weight Changes
Syndrome X
Topiramate
Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Abdominal obesity metabolic syndrome

Additional relevant MeSH terms:
Anti-Obesity Agents
Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Physiological Effects of Drugs
Central Nervous System Agents
Protective Agents
Neuroprotective Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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