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

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ClinicalTrials.gov Identifier: NCT00868140
Recruitment Status : Terminated (Lack of recruitment)
First Posted : March 24, 2009
Results First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Health Services Research
Condition Polycystic Ovary Syndrome
Interventions Drug: pioglitazone
Drug: Placebo
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1/Pioglitazaone Treated 2/Placebo
Hide Arm/Group Description

Pioglitazone treated subjects

pioglitazone: pioglitazone 45 mg

Placebo control to arm 1

Placebo: placebo daily

Period Title: Overall Study
Started 26 25
Completed 26 25
Not Completed 0 0
Arm/Group Title 1/Pioglitazaone Treated 2/Placebo Total
Hide Arm/Group Description

Pioglitazone treated subjects

pioglitazone: pioglitazone 45 mg

Placebo control to arm 1

Placebo: placebo daily

Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
A total of 32 obese (body mass index, BMI, greater than or equal to 30 kg/m2 PCOS women, between 18-40 years old, were studied during the equivalent of the follicular phase of the menstrual cycle, as documented by a serum progesterone of less than or equal to 2 ng/ml.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
16
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Females Number Analyzed 16 participants 16 participants 32 participants
16 16 32
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Hispanic or Latino
10
  62.5%
9
  56.3%
19
  59.4%
Not Hispanic or Latino
6
  37.5%
7
  43.8%
13
  40.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.3%
1
   6.3%
2
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   6.3%
1
   6.3%
2
   6.3%
White
14
  87.5%
14
  87.5%
28
  87.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Venezuela Number Analyzed 16 participants 16 participants 32 participants
16 16 32
1.Primary Outcome
Title AUC DCI-IPG (%/Min)
Hide Description 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.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Pioglitazaone Treated 2/Placebo
Hide Arm/Group Description:

Pioglitazone

pioglitazone: pioglitazone 45 mg

control to arm 1

Placebo: placebo daily

Overall Number of Participants Analyzed 16 16
Mean (Standard Error)
Unit of Measure: % bioactivity at time 0 of OGTT
13162.06  (1240.6) 14054.17  (1373.1)
2.Primary Outcome
Title AUC DCI-IPG (%/Min)
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Pioglitazaone Treated 2/Placebo
Hide Arm/Group Description:

Pioglitazone

pioglitazone: pioglitazone 45 mg

control to arm 1

Placebo: placebo daily

Overall Number of Participants Analyzed 16 16
Mean (Standard Error)
Unit of Measure: % bioactivity at time 0 of OGTT
-412.22  (1295.7) -699.45  (1890.71)
3.Primary Outcome
Title Fasting Serum Insulin
Hide Description 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
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Pioglitazaone Treated 2/Placebo
Hide Arm/Group Description:

Pioglitazone

pioglitazone: pioglitazone 45 mg

control to arm 1

Placebo: placebo daily

Overall Number of Participants Analyzed 16 16
Mean (Standard Error)
Unit of Measure: uIU.min/ml
15.04  (1.23) 15.91  (1.32)
4.Primary Outcome
Title Fasting Serum Insulin (uIU/ml)
Hide Description 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
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Pioglitazaone Treated 2/Placebo
Hide Arm/Group Description:

Pioglitazone treated subjects

pioglitazone: pioglitazone 45 mg

Placebo control to arm 1

Placebo: placebo daily

Overall Number of Participants Analyzed 16 16
Mean (Standard Error)
Unit of Measure: uIU.min/ml
-8.69  (1.23) -0.24  (1.50)
5.Secondary Outcome
Title Matsuda Index
Hide Description

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.

Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Pioglitazaone Treated 2/Placebo
Hide Arm/Group Description:

Pioglitazone

pioglitazone: pioglitazone 45 mg

control to arm 1

Placebo: placebo daily

Overall Number of Participants Analyzed 16 16
Mean (Standard Error)
Unit of Measure: units on a scale
3.36  (0.18) 3.05  (0.15)
6.Secondary Outcome
Title Matsuda Index
Hide Description Whole body insulin sensitivity as determined by the Matsuda Index
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1/Pioglitazaone Treated 2/Placebo
Hide Arm/Group Description:

Pioglitazone

pioglitazone: pioglitazone 45 mg

control to arm 1

Placebo: placebo daily

Overall Number of Participants Analyzed 16 16
Mean (Standard Error)
Unit of Measure: units on a scale
4.29  (0.36) 0.29  (0.17)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1/Pioglitazone 2/Placebo
Hide Arm/Group Description

Pioglitazone in pill form at 45mg twice per day for 6 months

pioglitazone: pioglitazone 45 mg

Placebo control to arm 1 in pill form identical to treatment form also twice per day for 6 months

Placebo: placebo daily

All-Cause Mortality
1/Pioglitazone 2/Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1/Pioglitazone 2/Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1/Pioglitazone 2/Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/26 (11.54%)      0/25 (0.00%)    
General disorders     
Edema * [1]  3/26 (11.54%)  3 0/25 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
weight gain due to edema
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. John Nestler
Organization: Virginia Commonwealth University
Phone: (804) 828-3389
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00868140     History of Changes
Other Study ID Numbers: VCUIRB4480
GCRC0824 ( Other Identifier: Virginia Commonwealth University )
First Submitted: March 22, 2009
First Posted: March 24, 2009
Results First Submitted: February 19, 2016
Results First Posted: June 10, 2016
Last Update Posted: June 10, 2016