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Effects of Pitavastatin on Insulin Sensitivity and Liver Fat

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.
 
ClinicalTrials.gov Identifier: NCT02290106
Recruitment Status : Completed
First Posted : November 13, 2014
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Takara Stanley, Massachusetts General Hospital

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 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.

Condition or disease Intervention/treatment Phase
Obesity Fatty Liver, Nonalcoholic Drug: pitavastatin Other: PLACEBO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pitavastatin on Insulin Sensitivity and Liver Fat
Actual Study Start Date : March 2, 2015
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Pitavastatin
pitavastatin 4mg daily by mouth for 6 months
Drug: pitavastatin
Other Name: Livalo

Placebo Comparator: Placebo
Identical placebo 4mg by mouth daily for 6 months
Other: PLACEBO



Primary Outcome Measures :
  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 Outcome Measures :
  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))



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men age 40-65yo
  2. BMI ≥ 27kg/m2 and waist circumference ≥102cm, high probability risk factors for NAFLD
  3. 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.
  4. 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
  5. 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:

  1. Diagnosis of diabetes or use of anti-diabetic medications.
  2. Use of erythromycin, rifampin, cyclosporin, colchicine, or gemfibrozil.
  3. 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.
  4. Contraindication to statin therapy.
  5. Creatinine > upper limit of normal or known renal disease
  6. AST or ALT > 3 times the upper limit of normal
  7. hemoglobin < 10g/dL
  8. Contraindication to undergoing a magnetic resonance scan.
  9. Atherosclerotic cardiovascular disease or low-density lipoprotein cholesterol (LDL-C) ≥ 190mg/dL.
  10. Triglyceride ≥500mg/dL

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 ClinicalTrials.gov identifier (NCT number): NCT02290106


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Steven K Grinspoon, MD Massachusetts General Hospital
Principal Investigator: Takara L Stanley, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Takara Stanley, Massachusetts General Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Takara Stanley, Assistant Professor of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02290106    
Other Study ID Numbers: 2014p-002117
First Posted: November 13, 2014    Key Record Dates
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019
Last Verified: June 2019
Keywords provided by Takara Stanley, Massachusetts General Hospital:
obesity
insulin sensitivity
statin (HMG-CoA Reductase Inhibitor)
fatty liver
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Insulin Resistance
Hypersensitivity
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents