Trial · NCT00470262
Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation
NCT00470262, Not applicable, Completed, VA Office of Research and Development; results first posted 2016-07-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation. Trials, record NCT00470262. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00470262
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation
- NCT number
- NCT00470262
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 27 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Metabolic Syndrome X, Prediabetic State
- Interventions
- Fenofibrate 145mg PO QD, Pioglitazone 45 mg PO QD
- First posted
- 2007-05-07
- Last updated
- 2016-07-21
- Results first posted
- 2016-07-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insulin Sensitivity | 3 months | Insulin sensitivity was measure through frequently sampled intravenous glucose tolerance test. Subjects presented to research center fasting. Blood samples were collected at -21, -11, and -1 minutes. At time t=0 initiates the start of the IVGTT and the injection of glucose into the non-sampling arm. The glucose dose was calculated as 11.4g/m2 of body surface area, given as a 50% dextrose solution. This glucose injection was administered over 60 seconds or less. At time t=20 minutes, an insulin dose of 0.04u/kg was administered over 30 seconds. Blood samples were collected at times t=2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 19, 22, 23, 24, 25, 27, 30, 40, 50, 70, 90, 100, 120, 140, 160, and 180. If blood sugar did not return to a steady state the test was continued to t= 210 or t= 240. |
| Secondary | IMCL | 3 months | Intramyocellular lipid was measured using immunohistochemistry (using oil Red O staining) in muscle biopsy specimens. Oil red O-stained muscle sections were magnified with an Olympus Provis (Tokyo, Japan) light microscope, and images were digitally captured by using a connected charge-coupled device camera (Sony, Tokyo, Japan). Fiber-typed and oil red O-stained fibers were matched. The oil red O staining intensity of either type 1 or 2 muscle fibers was quantified using National Institutes of Health Image program (http://rsb.info.nih.gov/nih-image/). By adjusting a density threshold, the software was set to recognize the presence of one fat droplet only if its highlighted surface was exceeding 0.40 μm2 or larger. Muscle lipid content was calculated by total area of lipid droplets in a given muscle fiber divided by the total area of the same fiber. The mean number of fibers analyzed per sample was 40 for type 1 and 2 muscle fibers |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Insulin Sensitivity | 3 months | mg*kg^-1*min^-1 | MEAN | |
| SECONDARY | IMCL | 3 months | % of lipid area stained | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Insulin Sensitivity | Fenofibrate 145mg PO QD | pre | 1.48 | Standard Deviation 0.64 | mg*kg^-1*min^-1 |
| Insulin Sensitivity | Fenofibrate 145 mg PO QD + Pioglitazone | pre | 1.73 | Standard Deviation 0.75 | mg*kg^-1*min^-1 |
| Insulin Sensitivity | Fenofibrate 145mg PO QD | post | 1.89 | Standard Deviation 0.88 | mg*kg^-1*min^-1 |
| Insulin Sensitivity | Fenofibrate 145 mg PO QD + Pioglitazone | post | 2.93 | Standard Deviation 1.3 | mg*kg^-1*min^-1 |
| IMCL | Fenofibrate 145mg PO QD | pre | 3.67 | Standard Deviation 1.30 | % of lipid area stained |
| IMCL | Fenofibrate 145mg PO QD + Pioglitazone 45mg PO BID | pre | 5.32 | Standard Deviation 0.65 | % of lipid area stained |
| IMCL | Fenofibrate 145mg PO QD | post | 3.46 | Standard Deviation 2.36 | % of lipid area stained |
| IMCL | Fenofibrate 145mg PO QD + Pioglitazone 45mg PO BID | post | 2.82 | Standard Deviation 0.56 | % of lipid area stained |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fenofibrate | 15 | |
| Overall Study | STARTED | Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD | 12 | |
| Overall Study | COMPLETED | Fenofibrate | 13 | |
| Overall Study | COMPLETED | Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD | 12 | |
| Overall Study | NOT COMPLETED | Fenofibrate | 2 | |
| Overall Study | NOT COMPLETED | Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Syncope | Nervous system disorders | Fenofibrate 145mg PO QD | 0 | 15 | 0 |
| other | Syncope | Nervous system disorders | Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD | 1 | 12 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fenofibrate 145mg PO QD | ||
| Total, all-cause mortality | Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD | ||
| Total, other adverse events | Fenofibrate 145mg PO QD | 0 | 15 |
| Total, other adverse events | Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD | 1 | 12 |
| Total, serious adverse events | Fenofibrate 145mg PO QD | 0 | 15 |
| Total, serious adverse events | Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33210751 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fenofibrate 145mg PO QD vs Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD: serious adverse events |
Source 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/NCT00470262
GET https://conductscience.org/api/trials/v1/NCT00470262/registered