Trial · NCT02290106
Effects of Pitavastatin on Insulin Sensitivity and Liver Fat
NCT02290106, Not applicable, Completed, Massachusetts General Hospital; results first posted 2019-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Pitavastatin on Insulin Sensitivity and Liver Fat. Trials, record NCT02290106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02290106
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Pitavastatin on Insulin Sensitivity and Liver Fat
- NCT number
- NCT02290106
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 50 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Obesity, Fatty Liver, Nonalcoholic
- Interventions
- pitavastatin, PLACEBO
- First posted
- 2014-11-13
- Last updated
- 2019-07-02
- Results first posted
- 2019-07-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insulin-stimulated Glucose Uptake | 6 months | insulin-stimulated glucose uptake measured by euglycemic hyperinsulinemic clamp |
| Primary | Liver Fat | 6 months | liver fat content as measured by 1H-magnetic resonance spectroscopy |
| Secondary | Alanine Aminotransferase (ALT) | 6 months | alanine aminotransferase at the 6 month timepoint |
| Secondary | Aspartate Aminotransferase (AST) | 6 months | aspartate aminotransferase at 6 month timepoint |
| Secondary | Hepatic Insulin Sensitivity | 6 months | hepatic insulin sensitivity assessed by glucose infusion rate corrected for fluctuations in serum glucose ("M") during low-dose insulin clamp |
| Secondary | Hemoglobin A1c (HbA1c) | 6 months | |
| Secondary | Quantitative Insulin Sensitivity Check Index (QUICKI) | 6 months | quantitative insulin sensitivity check index (QUICKI) at 6 months. Measure = 1/((log(glucose in mg/dL) + log(insulin in uU/mL)) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Insulin-stimulated Glucose Uptake | 6 months | All patients with results for baseline and final. In addition to 3 participants who did not finish the study, 2 participants were unable to undergo clamp. | mg/kg/minute | MEAN |
| PRIMARY | Liver Fat | 6 months | All participants with baseline and final data were analyzed. In addition to patients who discontinued from the study, some patients were unable to have MRI scan due to inability to fit in the scanner or unanticipated claustrophobia. | % liver fat (hepatic fat fraction) | MEAN |
| SECONDARY | Alanine Aminotransferase (ALT) | 6 months | all patients with available data at baseline and final | U/L | MEAN |
| SECONDARY | Aspartate Aminotransferase (AST) | 6 months | all patients with available data at baseline and final | U/L | MEAN |
| SECONDARY | Hepatic Insulin Sensitivity | 6 months | all patients with available data at baseline and final (note, in addition to 3 patients who discontinued, some patients were unable to undergo clamp procedure) | mg/kg/minute | MEAN |
| SECONDARY | Hemoglobin A1c (HbA1c) | 6 months | % (hemoglobin A1c) | MEAN | |
| SECONDARY | Quantitative Insulin Sensitivity Check Index (QUICKI) | 6 months | QUICKI index | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Insulin-stimulated Glucose Uptake | Pitavastatin | 5.9 | Standard Deviation 2.1 | mg/kg/minute | |
| Insulin-stimulated Glucose Uptake | Placebo | 5.9 | Standard Deviation 1.6 | mg/kg/minute | |
| Liver Fat | Pitavastatin | 17 | Standard Deviation 11 | % liver fat (hepatic fat fraction) | |
| Liver Fat | Placebo | 14 | Standard Deviation 10 | % liver fat (hepatic fat fraction) | |
| Alanine Aminotransferase (ALT) | Pitavastatin | 37 | Standard Deviation 38 | U/L | |
| Alanine Aminotransferase (ALT) | Placebo | 27 | Standard Deviation 17 | U/L | |
| Aspartate Aminotransferase (AST) | Pitavastatin | 31 | Standard Deviation 23 | U/L | |
| Aspartate Aminotransferase (AST) | Placebo | 26 | Standard Deviation 12 | U/L | |
| Hepatic Insulin Sensitivity | Pitavastatin | 1.5 | Standard Deviation 1.0 | mg/kg/minute | |
| Hepatic Insulin Sensitivity | Placebo | 1.6 | Standard Deviation 0.7 | mg/kg/minute |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pitavastatin | 25 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Pitavastatin | 24 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | NOT COMPLETED | Pitavastatin | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea or Loose Stools | Gastrointestinal disorders | Pitavastatin | 3 | 25 | |
| other | Diarrhea or Loose Stools | Gastrointestinal disorders | Placebo | 7 | 25 | |
| other | Any Gastrointestinal Symptoms | Gastrointestinal disorders | Pitavastatin | 5 | 25 | |
| other | Any Gastrointestinal Symptoms | Gastrointestinal disorders | Placebo | 8 | 25 | |
| other | Any Musculoskeletal Symptoms | Musculoskeletal and connective tissue disorders | Pitavastatin | 4 | 25 | |
| other | Any Musculoskeletal Symptoms | Musculoskeletal and connective tissue disorders | Placebo | 6 | 25 | |
| other | Muscle Cramps | Musculoskeletal and connective tissue disorders | Pitavastatin | 4 | 25 | |
| other | Muscle Cramps | Musculoskeletal and connective tissue disorders | Placebo | 4 | 25 | |
| other | Fatigue | General disorders | Pitavastatin | 2 | 25 | |
| other | Fatigue | General disorders | Placebo | 5 | 25 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pitavastatin | 0 | 25 |
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, other adverse events | Pitavastatin | 16 | 25 |
| Total, other adverse events | Placebo | 25 | 25 |
| Total, serious adverse events | Pitavastatin | 2 | 25 |
| Total, serious adverse events | Placebo | 1 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30239757 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pitavastatin vs Placebo: deaths from any cause | Trial comparisons |
| Pitavastatin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02290106
GET https://conductscience.org/api/trials/v1/NCT02290106/registered