Trial · NCT00868140

Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS)

NCT00868140, Not applicable, Terminated, Virginia Commonwealth University; results first posted 2016-06-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS). Trials, record NCT00868140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00868140

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Trial

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

Title: Effects of Pioglitazone on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS)
NCT number: NCT00868140
Status: Terminated
Phases: Not applicable
Enrollment: 51 participants, actual
Lead sponsor: Virginia Commonwealth University
Conditions: Polycystic Ovary Syndrome
Interventions: pioglitazone, Placebo
First posted: 2009-03-24
Last updated: 2016-06-10
Results first posted: 2016-06-10

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	AUC DCI-IPG (%/Min)	Baseline	Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT before treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.
Primary	AUC DCI-IPG (%/Min)	6 months	Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT following 6 months of treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.
Primary	Fasting Serum Insulin	baseline	Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT before treatment with either pioglitazone or placebo
Primary	Fasting Serum Insulin (uIU/ml)	6 months	Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT following 6 months treatment with either pioglitazone or placebo
Secondary	Matsuda Index	Baseline	Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula: 10,000 divided by the square root of (FPI\* FPG) \* (xGPC\* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance.
Secondary	Matsuda Index	6 months	Whole body insulin sensitivity as determined by the Matsuda Index

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	AUC DCI-IPG (%/Min)	Baseline	% bioactivity at time 0 of OGTT	MEAN
SECONDARY	Matsuda Index	Baseline	units on a scale	MEAN
PRIMARY	AUC DCI-IPG (%/Min)	6 months	% bioactivity at time 0 of OGTT	MEAN
PRIMARY	Fasting Serum Insulin	baseline	uIU.min/ml	MEAN
PRIMARY	Fasting Serum Insulin (uIU/ml)	6 months	uIU.min/ml	MEAN
SECONDARY	Matsuda Index	6 months	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
AUC DCI-IPG (%/Min)	1/Pioglitazaone Treated	13162.06	Standard Error 1240.6	% bioactivity at time 0 of OGTT
AUC DCI-IPG (%/Min)	2/Placebo	14054.17	Standard Error 1373.1	% bioactivity at time 0 of OGTT
Matsuda Index	1/Pioglitazaone Treated	3.36	Standard Error 0.18	units on a scale
Matsuda Index	2/Placebo	3.05	Standard Error 0.15	units on a scale
AUC DCI-IPG (%/Min)	1/Pioglitazaone Treated	-412.22	Standard Error 1295.7	% bioactivity at time 0 of OGTT
AUC DCI-IPG (%/Min)	2/Placebo	-699.45	Standard Error 1890.71	% bioactivity at time 0 of OGTT
Fasting Serum Insulin	1/Pioglitazaone Treated	15.04	Standard Error 1.23	uIU.min/ml
Fasting Serum Insulin	2/Placebo	15.91	Standard Error 1.32	uIU.min/ml
Fasting Serum Insulin (uIU/ml)	1/Pioglitazaone Treated	-8.69	Standard Error 1.23	uIU.min/ml
Fasting Serum Insulin (uIU/ml)	2/Placebo	-0.24	Standard Error 1.50	uIU.min/ml

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	1/Pioglitazaone Treated	26
Overall Study	STARTED	2/Placebo	25
Overall Study	COMPLETED	1/Pioglitazaone Treated	26
Overall Study	COMPLETED	2/Placebo	25
Overall Study	NOT COMPLETED	1/Pioglitazaone Treated	0
Overall Study	NOT COMPLETED	2/Placebo	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	Edema	General disorders	1/Pioglitazone	3	26	3
other	Edema	General disorders	2/Placebo	0	25	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1/Pioglitazone
Total, all-cause mortality	2/Placebo
Total, other adverse events	1/Pioglitazone	3	26
Total, other adverse events	2/Placebo	0	25
Total, serious adverse events	1/Pioglitazone	0	26
Total, serious adverse events	2/Placebo	0	25

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27028341	RESULT

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
1/Pioglitazone vs 2/Placebo: 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/NCT00868140

GET https://conductscience.org/api/trials/v1/NCT00868140/registered

API reference For AI assistants