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Effects of Pitavastatin on Insulin Sensitivity and Liver Fat

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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

Tracking Information
First Submitted Date  ICMJE November 8, 2014
First Posted Date  ICMJE November 13, 2014
Results First Submitted Date  ICMJE March 22, 2019
Results First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date  ICMJE March 2, 2015
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2014)
  • Insulin-stimulated Glucose Uptake [ Time Frame: 6 months ]
    insulin-stimulated glucose uptake measured by euglycemic hyperinsulinemic clamp
  • Liver Fat [ Time Frame: 6 months ]
    liver fat content as measured by 1H-magnetic resonance spectroscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Alanine Aminotransferase (ALT) [ Time Frame: 6 months ]
    alanine aminotransferase at the 6 month timepoint
  • Aspartate Aminotransferase (AST) [ Time Frame: 6 months ]
    aspartate aminotransferase at 6 month timepoint
  • 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
  • Hemoglobin A1c (HbA1c) [ Time Frame: 6 months ]
  • 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))
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2014)
  • Alanine Aminotransferase (ALT) [ Time Frame: 6 months ]
  • Aspartate Aminotransferase (AST) [ Time Frame: 6 months ]
  • Hepatic Insulin Sensitivity [ Time Frame: 6 months ]
    hepatic insulin sensitivity assessed by insulin suppression of hepatic gluconeogenesis during low-dose euglycemic hyperinsulinemic clamp
  • Hemoglobin A1c (HbA1c) [ Time Frame: 6 months ]
  • Quantitative Insulin Sensitivity Check Index (QUICKI) [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Pitavastatin on Insulin Sensitivity and Liver Fat
Official Title  ICMJE Effects of Pitavastatin on Insulin Sensitivity and Liver Fat
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Fatty Liver, Nonalcoholic
Intervention  ICMJE
  • Drug: pitavastatin
    Other Name: Livalo
  • Other: PLACEBO
Study Arms  ICMJE
  • Experimental: Pitavastatin
    pitavastatin 4mg daily by mouth for 6 months
    Intervention: Drug: pitavastatin
  • Placebo Comparator: Placebo
    Identical placebo 4mg by mouth daily for 6 months
    Intervention: Other: PLACEBO
Publications * Braun LR, Feldpausch MN, Czerwonka N, Weiss J, Branch K, Lee H, Martinez-Salazar EL, Torriani M, Sponseller CA, Grinspoon SK, Stanley TL. Effects of Pitavastatin on Insulin Sensitivity and Liver Fat: A Randomized Clinical Trial. J Clin Endocrinol Metab. 2018 Nov 1;103(11):4176-4186. doi: 10.1210/jc.2018-01446.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02290106
Other Study ID Numbers  ICMJE 2014p-002117
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takara Stanley, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven K Grinspoon, MD Massachusetts General Hospital
Principal Investigator: Takara L Stanley, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP