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Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome X, Diabetes Mellitus, Type 2

Status
Suspended
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
topiramate
Sponsored by
Northeastern Ohio Universities College of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring metabolic syndrome, type 2 diabetes, topiramate, weight loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Metabolic Syndrome BMI >/=30kg/m2 and 3 of the 5 following criteria: Triglycerides >/=150mg/dl HDL cholesterol </=40mg/dl (men) or </=50mg/dl (women) Blood pressure > 130/85 Waist circumference >/=40inches (men) or >/=35inches (women) 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.

Sites / Locations

  • Akron General Medical Center
  • Mercy Medical Center
  • Aultman Hospital
  • Forum Health/Northside Medical Center
  • St. Elizabeth Health Center

Outcomes

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.

Full Information

First Posted
October 21, 2005
Last Updated
December 7, 2007
Sponsor
Northeastern Ohio Universities College of Medicine
Collaborators
Cleveland Clinic Akron General, Forum Health, Aultman Health Foundation, St. Elizabeth Health Center, Mercy Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00243984
Brief Title
Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Suspended
Why Stopped
Study was discontinued because of high drop out rate.
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Northeastern Ohio Universities College of Medicine
Collaborators
Cleveland Clinic Akron General, Forum Health, Aultman Health Foundation, St. Elizabeth Health Center, Mercy Medical Center

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X, Diabetes Mellitus, Type 2
Keywords
metabolic syndrome, type 2 diabetes, topiramate, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
topiramate
Primary Outcome Measure Information:
Title
Change in weight on days 28, 56, 84, 112, 140, 168, and 175.
Title
Waist circumference on days 1, 84 and 168.
Title
BMI on days 1, 84, 168, and 175.
Secondary Outcome Measure Information:
Title
Blood pressure on days 1, 28, 56, 84, 112, 140, 168, and 175.
Title
Complete metabolic profile on days 84 and 168.
Title
HbA1C on days 1, 84, and 168.
Title
Lipid profile on days 84 and 168.
Title
C reactive protein on days 1, 84, and 168.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Metabolic Syndrome BMI >/=30kg/m2 and 3 of the 5 following criteria: Triglycerides >/=150mg/dl HDL cholesterol </=40mg/dl (men) or </=50mg/dl (women) Blood pressure > 130/85 Waist circumference >/=40inches (men) or >/=35inches (women) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Whittier, MD
Organizational Affiliation
Northeastern Ohio Universities College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Mercy Medical Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Forum Health/Northside Medical Center
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
St. Elizabeth Health Center
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States

12. IPD Sharing Statement

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Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

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