The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study
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ClinicalTrials.gov Identifier: NCT00400231 |
Recruitment Status
:
Completed
First Posted
: November 16, 2006
Last Update Posted
: March 20, 2017
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Sponsor:
University of Pennsylvania
Collaborator:
Abbott
Information provided by (Responsible Party):
University of Pennsylvania
Tracking Information | ||||
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First Submitted Date ICMJE | November 9, 2006 | |||
First Posted Date ICMJE | November 16, 2006 | |||
Last Update Posted Date | March 20, 2017 | |||
Study Start Date ICMJE | August 2005 | |||
Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
triglyceride levels [ Time Frame: 5 months ] | |||
Original Primary Outcome Measures ICMJE |
triglyceride levels | |||
Change History | Complete list of historical versions of study NCT00400231 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
HDL-C, Resistin, insulin resistance [ Time Frame: 5 months ] | |||
Original Secondary Outcome Measures ICMJE |
HDL-C, insulin resistance, and inflammatory markers | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study | |||
Official Title ICMJE | The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Diagnostic |
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Condition ICMJE | Metabolic Syndrome x | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
124 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | March 2008 | |||
Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | 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:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00400231 | |||
Other Study ID Numbers ICMJE | 800860 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of Pennsylvania | |||
Study Sponsor ICMJE | University of Pennsylvania | |||
Collaborators ICMJE | Abbott | |||
Investigators ICMJE |
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PRS Account | University of Pennsylvania | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |