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| Sponsor: | University of Pennsylvania |
|---|---|
| Collaborator: |
Abbott |
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00400231 |
Purpose
Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate; or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C, insulin resistance, and markers of inflammation.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome X |
Drug: Study drugs: Metformin and fenofibrate Drug: Study Drug: Metformin Drug: Study Drug: fenofibrate Drug: Metformin and Fenofibrate placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic |
| Official Title: | The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study |
| Estimated Enrollment: | 124 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | November 2008 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Metformin
|
Drug: Study Drug: Metformin
2000mg/day
|
|
Active Comparator: 2
Fenofibrate
|
Drug: Study Drug: fenofibrate
145mg/day of fenofibrate
|
|
Active Comparator: 3
Fenofibrate and Metformin
|
Drug: Study drugs: Metformin and fenofibrate
145mg fenofibrate once/day and 2000mg/day of metformin for arm 3.
|
| Placebo Comparator: 4 |
Drug: Metformin and Fenofibrate placebo
placebo metformin and fenofibrate
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects between the ages of 18 and 75 with both of the following risk factors:
And at least one of the following three:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Frederick F. Samaha, M.D. | University of Pennsylvania |
More Information
| Responsible Party: | Frederick F. Samaha, MD, UPenn |
| ClinicalTrials.gov Identifier: | NCT00400231 History of Changes |
| Other Study ID Numbers: | 800860 |
| Study First Received: | November 9, 2006 |
| Last Updated: | January 8, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
metabolic syndrome Triglycerides Insulin Resistance inflammation |
Cardiovascular Disease Elevated triglycerides without diabetes |
|
Dyslipidemias Metabolic Syndrome X Lipid Metabolism Disorders Metabolic Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metformin Fenofibrate |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Therapeutic Uses |