Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243984
Status:
SUSPENDED
Last Update Posted:
2007-12-10
First Post:
2005-10-21
Brief Title:
Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome
Sponsor:
Northeastern Ohio Universities College of Medicine
Organization:
Northeastern Ohio Universities College of Medicine
Study Overview
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
Status:
SUSPENDED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was discontinued because of high drop out rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None