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Completed

NCT Number: NCT02290106

Effects of Pitavastatin on Insulin Sensitivity and Liver Fat

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 statins are well-known, other metabolic effects, including effects on glucose tolerance and ectopic fat distribution, are less completely understood. Recent studies have shown that some statins may increase the risk of diabetes. Further, research has suggested that statins may have some benefit in nonalcoholic fatty liver disease (NAFLD), a condition associated with obesity that includes increased fat in the liver (steatosis) and, in some cases, inflammation and hepatocellular damage (steatohepatitis). Pitavastatin, approved by the United States Food and Drug Administration (FDA) in 2009, is the most recent statin to enter the market. Unlike most statins, pitavastatin is not primarily metabolized through cytochrome P450 (CYP450), and thus has reduced potential for interactions with other medications that are metabolized by CYP450. Previous studies have suggested that pitavastatin may be neutral to glucose homeostasis and may improve hepatic lipid. Neither of these effects has been proven definitively, however, and the current proposal aims to characterize in detail the effects of pitavastatin on glucose homeostasis, hepatic steatosis, and steatohepatitis.

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Key information

Conditions

Obesity Body Weight Digestive System Diseases Fatty Liver Fatty Liver, Nonalcoholic Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Pitavastatin

Drug

Other names: Livalo

Placebo

Other

Primary outcomes

  1. Insulin-stimulated Glucose Uptake

    Time frame: 6 months

    insulin-stimulated glucose uptake measured by euglycemic hyperinsulinemic clamp

  2. Liver Fat

    Time frame: 6 months

    liver fat content as measured by 1H-magnetic resonance spectroscopy

Secondary outcomes

  1. Alanine Aminotransferase (ALT)

    Time frame: 6 months

    alanine aminotransferase at the 6 month timepoint

  2. Aspartate Aminotransferase (AST)

    Time frame: 6 months

    aspartate aminotransferase at 6 month timepoint

  3. Hepatic Insulin Sensitivity

    Time frame: 6 months

    hepatic insulin sensitivity assessed by glucose infusion rate corrected for fluctuations in serum glucose ("M") during low-dose insulin clamp

  4. Hemoglobin A1c (HbA1c)

    Time frame: 6 months

  5. Quantitative Insulin Sensitivity Check Index (QUICKI)

    Time frame: 6 months

    quantitative insulin sensitivity check index (QUICKI) at 6 months. Measure = 1/((log(glucose in mg/dL) + log(insulin in uU/mL))

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2014
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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