- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02290106
Effects of Pitavastatin on Insulin Sensitivity and Liver Fat
June 12, 2019 updated by: Takara Stanley, Massachusetts General Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pitavastatin
pitavastatin 4mg daily by mouth for 6 months
|
Other Names:
|
Placebo Comparator: Placebo
Identical placebo 4mg by mouth daily for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin-stimulated Glucose Uptake
Time Frame: 6 months
|
insulin-stimulated glucose uptake measured by euglycemic hyperinsulinemic clamp
|
6 months
|
Liver Fat
Time Frame: 6 months
|
liver fat content as measured by 1H-magnetic resonance spectroscopy
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alanine Aminotransferase (ALT)
Time Frame: 6 months
|
alanine aminotransferase at the 6 month timepoint
|
6 months
|
Aspartate Aminotransferase (AST)
Time Frame: 6 months
|
aspartate aminotransferase at 6 month timepoint
|
6 months
|
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
|
6 months
|
Hemoglobin A1c (HbA1c)
Time Frame: 6 months
|
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))
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven K Grinspoon, MD, Massachusetts General Hospital
- Principal Investigator: Takara L Stanley, MD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2015
Primary Completion (Actual)
April 30, 2018
Study Completion (Actual)
April 30, 2018
Study Registration Dates
First Submitted
November 8, 2014
First Submitted That Met QC Criteria
November 8, 2014
First Posted (Estimate)
November 13, 2014
Study Record Updates
Last Update Posted (Actual)
July 2, 2019
Last Update Submitted That Met QC Criteria
June 12, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Liver Diseases
- Hyperinsulinism
- Hypersensitivity
- Fatty Liver
- Insulin Resistance
- Non-alcoholic Fatty Liver Disease
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Pitavastatin
Other Study ID Numbers
- 2014p-002117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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