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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: Completed NA study of Obesity and Fatty Liver, Nonalcoholic, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
insulin-stimulated glucose uptake measured by euglycemic hyperinsulinemic clamp
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 |
What the finished NCT02290106 record still lists
NCT02290106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02290106's enrollment target sits among peer trials
50 714th of 1053 higher than 324 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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