Trial · NCT01156597

Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes

NCT01156597, Phase 3, Completed, University of Miami; results first posted 2014-11-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes. Trials, record NCT01156597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01156597

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes
NCT number: NCT01156597
Status: Completed
Phases: Phase 3
Enrollment: 30 participants, actual
Lead sponsor: University of Miami
Conditions: Type 2 Diabetes Mellitus
Interventions: pioglitazone
First posted: 2010-07-05
Last updated: 2014-11-21
Results first posted: 2014-11-11

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Increased HDL-Cholesterol and Decreased Triglycerides	24 weeks	The primary endpoint will be increased high density lipoprotein cholesterol and decreased triglycerides measured as the difference after 12 or 24 weeks of treatment from baseline levels. The data are expressed as the percent change from the baseline value and calculated using he equation: * Change=\[100%\*(Endpoint value - Baseline Value)/Baseline Value\]
Secondary	HDL Apolipoprotein Levels at Study End-point	24 weeks	Lipoproteins will be isolated and analyzed using the gradient ultracentrifugation-high pressure liquid chromatography technique to isolate very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL), LDL, and high density lipoprotein (HDL) subfractions. Protein and lipid compositions of HDL is determined
Secondary	Cholesterol Efflux Capacity of HDL	24 weeks	The ability of serum HDL to remove cholesterol from cultured cells will be assessed as an in vitro method to evaluate a functional changes in HDL mediated by changes due to pioglitazone treatment. Cells were incubated with 2% serum from each study subject diluted in culture medium and incubations were performed for a total of 4 hours. Cholesterol efflux was calculated as the percent of cholesterol removed from the cells and appearing in the culture medium normalized to a reference serum pool as described in detail by de la Llera-Moya et al (de la Llera-Moya M, Drazul-Schrader D, Asztalos BF, Cuchel M, Rader DJ, Rothblat GH. The ability to promote efflux via ABCA1 determines the capacity of serum specimens with similar high-density lipoprotein cholesterol to remove cholesterol from macrophages. Arterioscler Thromb Vasc Biol. 2010 Apr;30(4):796-801. doi: 10.1161/ATVBAHA.109.199158. PMID: 20075420).

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Increased HDL-Cholesterol and Decreased Triglycerides	24 weeks	All subjects that completed the study were used for the final analysis	% Change	MEAN
SECONDARY	HDL Apolipoprotein Levels at Study End-point	24 weeks		mg/dL	MEAN
SECONDARY	Cholesterol Efflux Capacity of HDL	24 weeks		Ratio	MEAN

Source ClinicalTrials.gov

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Increased HDL-Cholesterol and Decreased Triglycerides	Pioglitazone Group	% Change in HDL cholesterol at 12 weeks	7.9	Standard Deviation 15.3	% Change
Increased HDL-Cholesterol and Decreased Triglycerides	Comparator Group	% Change in HDL cholesterol at 12 weeks	2.7	Standard Deviation 9.9	% Change
Increased HDL-Cholesterol and Decreased Triglycerides	Pioglitazone Group	% Change in HDL cholesterol at 24 weeks	15.7	Standard Deviation 5.9	% Change
Increased HDL-Cholesterol and Decreased Triglycerides	Comparator Group	% Change in HDL cholesterol at 24 weeks	-1.5	Standard Deviation 3.8	% Change
Increased HDL-Cholesterol and Decreased Triglycerides	Pioglitazone Group	% Change in triglycerides at 12 weeks	-10.9	Standard Deviation 26.6	% Change
Increased HDL-Cholesterol and Decreased Triglycerides	Comparator Group	% Change in triglycerides at 12 weeks	7.4	Standard Deviation 33.5	% Change
Increased HDL-Cholesterol and Decreased Triglycerides	Pioglitazone Group	% Change in triglycerides at 24 weeks	-15.4	Standard Deviation 6.3	% Change
Increased HDL-Cholesterol and Decreased Triglycerides	Comparator Group	% Change in triglycerides at 24 weeks	19.7	Standard Deviation 11.3	% Change
HDL Apolipoprotein Levels at Study End-point	Pioglitazone Group	HDL-apoAI at end point	65.0	Standard Deviation 0.9	mg/dL
HDL Apolipoprotein Levels at Study End-point	Comparator Group	HDL-apoAI at end point	65.7	Standard Deviation 7.0	mg/dL

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pioglitazone Group	16
Overall Study	STARTED	Comparator Group	14
Overall Study	COMPLETED	Pioglitazone Group	13
Overall Study	COMPLETED	Comparator Group	13
Overall Study	NOT COMPLETED	Pioglitazone Group	3
Overall Study	NOT COMPLETED	Comparator Group	1

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pioglitazone Group
Total, all-cause mortality	Comparator Group
Total, other adverse events	Pioglitazone Group	0	16
Total, other adverse events	Comparator Group	0	14
Total, serious adverse events	Pioglitazone Group	0	16
Total, serious adverse events	Comparator Group	0	14

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
11160777	BACKGROUND	PubMed
14553867	BACKGROUND	PubMed
15055868	BACKGROUND	PubMed
15632102	BACKGROUND	PubMed
15739120	BACKGROUND	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
Pioglitazone Group vs Comparator Group: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01156597

GET https://conductscience.org/api/trials/v1/NCT01156597/results?page=2

API reference For AI assistants