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| Sponsor: | Northeastern Ohio Universities College of Medicine |
|---|---|
| Collaborators: |
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | November 2007 |
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 |
Inclusion Criteria:
and 3 of the 5 following criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| Mercy Medical Center | |
| Canton, Ohio, United States, 44708 | |
| Aultman Hospital | |
| Canton, Ohio, United States, 44710 | |
| St. Elizabeth Health Center | |
| Youngstown, Ohio, United States, 44501 | |
| Forum Health/Northside Medical Center | |
| Youngstown, Ohio, United States, 44501 | |
| Principal Investigator: | Frederick Whittier, MD | Northeastern Ohio Universities College of Medicine |
More Information
| ClinicalTrials.gov Identifier: | NCT00243984 History of Changes |
| Other Study ID Numbers: | 05005 |
| Study First Received: | October 21, 2005 |
| Last Updated: | December 7, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
metabolic syndrome type 2 diabetes topiramate weight loss |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Weight Loss Metabolic Syndrome X Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Body Weight Changes Body Weight Signs and Symptoms Insulin Resistance |
Hyperinsulinism Topiramate Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |