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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
1/Pioglitazaone Treated

Pioglitazone treated subjects

pioglitazone: pioglitazone 45 mg

2/Placebo

Placebo control to arm 1

Placebo: placebo daily


Participant Flow:   Overall Study
    1/Pioglitazaone Treated   2/Placebo
STARTED   26   25 
COMPLETED   26   25 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
1/Pioglitazaone Treated

Pioglitazone treated subjects

pioglitazone: pioglitazone 45 mg

2/Placebo

Placebo control to arm 1

Placebo: placebo daily

Total Total of all reporting groups

Baseline Measures
   1/Pioglitazaone Treated   2/Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   16   32 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   16   16   32 
>=65 years   0   0   0 
Gender, Customized 
[Units: Participants]
     
Females   16   16   32 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   10   9   19 
Not Hispanic or Latino   6   7   13 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   1   2 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   1   2 
White   14   14   28 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Venezuela   16   16   32 


  Outcome Measures

1.  Primary:   AUC DCI-IPG (%/Min)   [ Time Frame: Baseline ]

2.  Primary:   AUC DCI-IPG (%/Min)   [ Time Frame: 6 months ]

3.  Primary:   Fasting Serum Insulin   [ Time Frame: baseline ]

4.  Primary:   Fasting Serum Insulin (uIU/ml)   [ Time Frame: 6 months ]

5.  Secondary:   Matsuda Index   [ Time Frame: Baseline ]

6.  Secondary:   Matsuda Index   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: john.nestler@vcuhealth.org


Publications of Results:

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