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Sponsors and Collaborators: |
Northeastern Ohio Universities College of Medicine Forum Health Aultman Health Foundation St. Elizabeth Health Center Mercy Medical Center |
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Information provided by: | Northeastern Ohio Universities College of Medicine |
ClinicalTrials.gov Identifier: | NCT00243984 |
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 |
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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 |
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.
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:
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 |
Principal Investigator: | Frederick Whittier, MD | Northeastern Ohio Universities College of Medicine |
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 |
metabolic syndrome type 2 diabetes topiramate weight loss |
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 |
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 |