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Trial record 6 of 23 for:    "Hyperinsulinism" | "Fenofibrate"

The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400231
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : March 20, 2017
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome x Drug: Study drugs: Metformin and fenofibrate Drug: Study Drug: Metformin Drug: Study Drug: fenofibrate Drug: Metformin and Fenofibrate placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study
Study Start Date : August 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : March 2008

Arm Intervention/treatment
Active Comparator: 1
Drug: Study Drug: Metformin

Active Comparator: 2
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

Primary Outcome Measures :
  1. triglyceride levels [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. HDL-C, Resistin, insulin resistance [ Time Frame: 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Subjects between the ages of 18 and 75 with both of the following risk factors:

  1. Fasting triglycerides >= 150 mg/dl (but less than 800 mg/dl)
  2. Glucose of 140 to 199 mg/dl, 2 hours after a 75 gm oral glucose load, a fasting HOMA level in the upper quartile (> 2.68), or a plasma triglyceride to high density lipoprotein cholesterol concentration > 3.0

And at least one of the following three:

  1. Central obesity (waist size > 40 inches in men or >35 inches in women)
  2. A systolic blood Pressure of >130 mmHg and/or a diastolic blood pressure of >85 mmHg and/or taking an antihypertensive medication.
  3. HDL < 40 mg/dl for men or < 50 mg/dl for women

Exclusion Criteria:

  1. Blood pressure > 180/95 mmHg (subjects may be re-screened after adequate blood pressure control has been obtained)
  2. Women who are pregnant or lactating, or who are of child-bearing potential and not using an acceptable method of birth control.
  3. Chronic renal insufficiency (serum creatinine >1.5 mg/dl in men and > 1.4 mg/dl in women
  4. Any active liver disease or abnormal LFTs (>2x upper limit normal)(12)
  5. Active infection, malignancy or chronic inflammatory disorder
  6. Concomitant use of niacin, a bile acid sequestrant, or ezetimibe. If it is deemed safe by the patient's primary physician and by the principal investigator, patients may be screened for enrollment upon stopping these medications for at least 2 weeks.
  7. Subjects on statins will need to be on less than maximal dose (e.g. < 80 mg per day for simvastatin or atorvastatin). Subjects will also need to have been on a stable dose of statin therapy for at least 1 month prior to enrollment and continue their currently prescribed statin at the same dose throughout the study. If it is deemed safe by the patient's primary physician and by the principal investigator, patients on maximal statin therapy (usually 80 mg/day) may reduce their dose of statin therapy to a sub maximal dose (usually 40 mg/day) for 4 weeks prior to screening for enrollment.
  8. History of lactic acidosis(12)
  9. Expected need for use of intravenous radiographic contrast during the study
  10. More than moderate alcohol use (> 14 drinks per week)
  11. Moderate to severe left ventricular dysfunction (ejection fraction <45%)
  12. Decompensated heart failure or decompensated lung disease that has resulted in hypoxia or reduced peripheral perfusion within the past year regardless of left ventricular ejection fraction (thus patients with underlying heart disease, coronary artery disease, mild left ventricular dysfunction (ejection fraction > 45%), or lung disease that has been stable for at least one year will be eligible to participate)
  13. Creatinine kinase (CK) levels ≥ 2.5 ULN or history of statin-induced myopathy. Patients with a CK level more than 2.5 times the upper limit of normal may undergo repeat testing up to two more times before being excluded (since vigorous physical activity can often elevate CK levels, and this would not increase the risk of myopathy).
  14. Participation in an investigational drug study within 6 weeks prior to the screening visit
  15. Surgery within the previous 30 days
  16. Concomitant use of ketoconazole, itraconazole, cyclosporin A, erythromycin, or Clarithromycin.
  17. Hemoglobin < 10 mg/dl, active use of coumadin, history of bleeding disorder, or abnormal clotting time (protime >14.6 seconds and aPTT > 37.0)
  18. Septic shock
  19. Acute coronary syndrome or stroke within 3 months prior to study
  20. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400231

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: Frederick F. Samaha, M.D. University of Pennsylvania

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Responsible Party: University of Pennsylvania Identifier: NCT00400231     History of Changes
Other Study ID Numbers: 800860
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

Keywords provided by University of Pennsylvania:
metabolic syndrome
Insulin Resistance
Cardiovascular Disease
Elevated triglycerides
without diabetes

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents