The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

NCT00400231 | Completed Phase 2

• 1 other identifier: 800860
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome x

Keywords

metabolic syndrome; Triglycerides; Insulin Resistance; inflammation; Cardiovascular Disease; Elevated triglycerides; without diabetes

Outcome Measures

Primary Outcomes (1)

• triglyceride levels

  5 months

Secondary Outcomes (1)

• HDL-C, Resistin, insulin resistance

  5 months

Study Arms (4)

1

ACTIVE COMPARATOR

Metformin

Drug: Study Drug: Metformin

2

ACTIVE COMPARATOR

Fenofibrate

Drug: Study Drug: fenofibrate

3

ACTIVE COMPARATOR

Fenofibrate and Metformin

Drug: Study drugs: Metformin and fenofibrate

4

PLACEBO COMPARATOR

Drug: Metformin and Fenofibrate placebo

Interventions

Study drugs: Metformin and fenofibrate DRUG

145mg fenofibrate once/day and 2000mg/day of metformin for arm 3.

3

Study Drug: Metformin DRUG

2000mg/day

1

Study Drug: fenofibrate DRUG

145mg/day of fenofibrate

2

Metformin and Fenofibrate placebo DRUG

placebo metformin and fenofibrate

4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects between the ages of 18 and 75 with both of the following risk factors:
• Fasting triglycerides \>= 150 mg/dl (but less than 800 mg/dl)
• 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:
• Central obesity (waist size \> 40 inches in men or \>35 inches in women)
• A systolic blood Pressure of \>130 mmHg and/or a diastolic blood pressure of \>85 mmHg and/or taking an antihypertensive medication.
• HDL \< 40 mg/dl for men or \< 50 mg/dl for women

You may not qualify if:

• Blood pressure \> 180/95 mmHg (subjects may be re-screened after adequate blood pressure control has been obtained)
• Women who are pregnant or lactating, or who are of child-bearing potential and not using an acceptable method of birth control.
• Chronic renal insufficiency (serum creatinine \>1.5 mg/dl in men and \> 1.4 mg/dl in women
• Any active liver disease or abnormal LFTs (\>2x upper limit normal)(12)
• Active infection, malignancy or chronic inflammatory disorder
• 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.
• 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.
• History of lactic acidosis(12)
• Expected need for use of intravenous radiographic contrast during the study
• More than moderate alcohol use (\> 14 drinks per week)
• Moderate to severe left ventricular dysfunction (ejection fraction \<45%)
• 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)
• 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).
• Participation in an investigational drug study within 6 weeks prior to the screening visit
• Surgery within the previous 30 days

Sponsors & Collaborators

• University of Pennsylvania: lead
• Abbott: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Inflammation; Cardiovascular Diseases; Hypertriglyceridemia

Interventions

Fenofibrate; Metformin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Biguanides; Guanidines; Amidines

Study Officials

• Frederick F. Samaha, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 16, 2006
• Study Start: August 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: March 1, 2008
• Last Updated: March 20, 2017

Record last verified: 2017-03

Locations

US (1)