Status:
COMPLETED
Effects of Pitavastatin on Insulin Sensitivity and Liver Fat
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Obesity
Fatty Liver, Nonalcoholic
Eligibility:
MALE
40-65 years
Phase:
NA
Brief Summary
HMG co-A reductase inhibitors, commonly called statins, are an effective treatment for dyslipidemia and atherosclerotic heart disease with proven mortality benefit. While the lipid-lowering effects of...
Eligibility Criteria
Inclusion
- Men age 40-65yo
- BMI ≥ 27kg/m2 and waist circumference ≥102cm, high probability risk factors for NAFLD
- At least one of the following indicating insulin resistance: Fasting glucose ≥100mg/dL and \<126mg/dL, HOMA-IR \>2.0, and/or 2 hour glucose ≥140mg/dL and \<200mg/dL following standard glucose tolerance test.
- 10-year cardiovascular disease risk ≥5% by American Heart Association(AHA)/American College of Cardiology (ACC) Pooled Cohort Equations CV Risk Calculator or LDL ≥ 100mg/dL
- No use of any statin within 1 year of study entry and not being actively considered for statin therapy by a treating provider.
Exclusion
- Diagnosis of diabetes or use of anti-diabetic medications.
- Use of erythromycin, rifampin, cyclosporin, colchicine, or gemfibrozil.
- Use of statin therapy within 1 year prior to study entry as above. Use of any other lipid-modifying therapy (including fish oil, fibrates, niacin, gemfibrozil) within 6 months of study entry.
- Contraindication to statin therapy.
- Creatinine \> upper limit of normal or known renal disease
- AST or ALT \> 3 times the upper limit of normal
- hemoglobin \< 10g/dL
- Contraindication to undergoing a magnetic resonance scan.
- Atherosclerotic cardiovascular disease or low-density lipoprotein cholesterol (LDL-C) ≥ 190mg/dL.
- Triglyceride ≥500mg/dL
Key Trial Info
Start Date :
March 2 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02290106
Start Date
March 2 2015
End Date
April 30 2018
Last Update
July 2 2019
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114