Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01156597 · ClinicalTrials.gov registry record · Phase 3
Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes
A Phase 3 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT01156597 is a Phase 3 study that has completed, run by University of Miami. The registered enrollment target is 30 participants.
The verdict
NCT01156597, a Phase 3 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
Metabolic defects contributing to the development of type 2 diabetes (T2D) are relative insulin insufficiency and insulin resistance that are associated with a cluster of abnormalities that increase the risk for cardiovascular disease including dyslipidemia, inflammation, hemodynamic changes and endothelial dysfunction. The dyslipidemia associated with T2D is characterized by elevated triglycerides and decreased high-density lipoprotein-cholesterol (HDL). The ability of the insulin sensitizing agent pioglitazone (ACTOS®) , to improve hyperglycemia in subjects with T2D is now well established. Pioglitazone functions as a PPAR-γ (peroxisome proliferator-activated receptor gamma) agonists and this class of drugs have demonstrated several other potential benefits, beyond glucose homeostasis. Specifically pioglitazone can improve diabetic dyslipidemia by increasing HDL cholesterol and lowing triglycerides. A potential beneficial effect on reverse cholesterol transport may be mediated by the increased HDL levels. This proposal aims to examine the effect of PPAR-γ activation by PIO on various aspects of reverse cholesterol transport by testing the hypothesis that PIO treatment affects key steps in the reverse cholesterol transport pathway either directly, through induction of protein expression, or indirectly, by altering HDL structure and composition leading to increase cholesterol flux through this pathway.
Interventions
- DRUG pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01156597
The ClinicalTrials.gov registry entry for NCT01156597 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which pioglitazone is the first listed.
NCT01156597 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01156597 about?
NCT01156597 is a clinical study titled "Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes". Metabolic defects contributing to the development of type 2 diabetes (T2D) are relative insulin insufficiency and insulin resistance that are associated with a cluster of abnormalities that increase the risk for cardiovascular disease including dyslipidemia, inflammation, hemodynamic changes and end...
What is the current status of trial NCT01156597?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2008-04. Estimated completion is 2010-09.
What interventions are being tested in trial NCT01156597?
The interventions under investigation include: pioglitazone (DRUG).
Who is sponsoring clinical trial NCT01156597?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.