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NCT02290106 · ClinicalTrials.gov registry record · NA
Effects of Pitavastatin on Insulin Sensitivity and Liver Fat
A NA study of Obesity and Fatty Liver, Nonalcoholic, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT02290106 is a NA study of Obesity and Fatty Liver, Nonalcoholic that has completed, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02290106, a NA study of Obesity and Fatty Liver, Nonalcoholic, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER PLACEBO
- DRUG pitavastatin
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-03-02 |
| Est. Completion | 2018-04-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02290106
The ClinicalTrials.gov registry entry for NCT02290106 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which PLACEBO is the first listed.
NCT02290106 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02290106 about?
NCT02290106 is a clinical study titled "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...
What is the current status of trial NCT02290106?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2015-03-02. Estimated completion is 2018-04-30.
What conditions does trial NCT02290106 study?
This clinical trial studies the following conditions: Obesity, Fatty Liver, Nonalcoholic.
What interventions are being tested in trial NCT02290106?
The interventions under investigation include: PLACEBO (OTHER), pitavastatin (DRUG).
Who is sponsoring clinical trial NCT02290106?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02290106 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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