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ObesityNCT02290106

Effects of Pitavastatin on Insulin Sensitivity and Liver Fat

A study testing pitavastatin in people with Obesity and Fatty Liver, Nonalcoholic, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 65 years, men only
Conditions the study is for
Obesity, Fatty Liver, Nonalcoholic
What is being tested?
pitavastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited States
Study dates
2 Mar 2015to 30 Apr 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Being tested
pitavastatin, PLACEBO
Keywords
obesity, insulin sensitivity, statin (HMG-CoA Reductase Inhibitor), fatty liver
Medical subject headings
Obesity, Non-alcoholic Fatty Liver Disease, Insulin Resistance, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pitavastatinDrug

    Also called Livalo

  • PLACEBOOther

Study groups in NCT02290106
Study groupRoleWhat they receive
PitavastatinExperimentalpitavastatin 4mg daily by mouth for 6 months
Receives: Drug: pitavastatin
PlaceboPlacebo comparatorIdentical placebo 4mg by mouth daily for 6 months
Receives: Other: PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin-stimulated Glucose Uptake

    insulin-stimulated glucose uptake measured by euglycemic hyperinsulinemic clamp

    Measured: 6 months

  2. Liver Fat

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

    Measured: 6 months

Secondary outcomes (5)

  1. Alanine Aminotransferase (ALT)

    alanine aminotransferase at the 6 month timepoint

    Measured: 6 months

  2. Aspartate Aminotransferase (AST)

    aspartate aminotransferase at 6 month timepoint

    Measured: 6 months

  3. Hepatic Insulin Sensitivity

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

    Measured: 6 months

  4. Hemoglobin A1c (HbA1c)

    Measured: 6 months

  5. Quantitative Insulin Sensitivity Check Index (QUICKI)

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2014 (estimated)
  2. Study start2 Mar 2015
  3. Primary completion30 Apr 2018
  4. Study completion30 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02290106
Sponsor's protocol ID
2014p-002117
Status last verified
Jun 2019
First submitted
8 Nov 2014
Last updated
2 Jul 2019
Data monitoring committee
No

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.

    PubMed 30239757

Questions about this trial

What is this clinical trial studying?

A study testing pitavastatin in people with Obesity and Fatty Liver, Nonalcoholic, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin-stimulated Glucose Uptake (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02290106, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.

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