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Trial record 14 of 30 for:    nichd Polycystic Ovary Syndrome (PCOS)

Insulin and Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT00683774
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : August 21, 2014
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: PCOS
Intervention: Drug: diazoxide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PCOS Subjects

PCOS subjects given diazoxide

diazoxide: 100mg orally three times per day for 10 days

Normal Subjects

Normal subjects given diazoxide

diazoxide: 100mg orally three times per day for 10 days


Participant Flow:   Overall Study
    PCOS Subjects   Normal Subjects
STARTED   11   10 
COMPLETED   8   9 
NOT COMPLETED   3   1 
Withdrawal by Subject                0                1 
Physician Decision                3                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.
Obese women with and without PCOS between the ages of 18-40 years selected after examination and eligibility screening

Reporting Groups
  Description
PCOS Subjects

PCOS subjects given diazoxide

diazoxide: 100mg orally three times per day for 10 days

Normal Subjects

Normal subjects given diazoxide

diazoxide: 100mg orally three times per day for 10 days

Total Total of all reporting groups

Baseline Measures
   PCOS Subjects   Normal Subjects   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   9   17 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      8 100.0%      9 100.0%      17 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8 100.0%      9 100.0%      17 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   8   9   17 
BMI (Body Mass Index) 
[Units: Kg/m^2]
Mean (Full Range)
 41.0 
 (32.7 to 49.2) 
 38.4 
 (33.3 to 43.4) 
 39.7 
 (32.7 to 49.2) 
Waist-to-hip ratio (WHR) 
[Units: Unitless]
Mean (Full Range)
 0.84 
 (0.81 to 0.88) 
 0.78 
 (0.72 to 0.84) 
 0.81 
 (0.72 to 0.88) 
Sex hormone binding globulin (SHBG) (nmol/L) 
[Units: nmol/L]
Mean (Full Range)
 32.1 
 (23.3 to 44.2) 
 45.6 
 (33.7 to 61.7) 
 38.9 
 (23.3 to 61.7) 
Total testosterone (ng/mL) 
[Units: ng/mL]
Mean (Full Range)
 2.2 
 (1.2 to 3.8) 
 1.1 
 (0.6 to 1.8) 
 1.7 
 (0.6 to 3.8) 
Free testosterone (pmol/L) 
[Units: pmol/L]
Mean (Full Range)
 144.3 
 (73.1 to 285.1) 
 57.7 
 (30.4 to 109.6) 
 101 
 (30.4 to 285.1) 
Fasting glucose (mg/dl) 
[Units: Mg/dl]
Mean (Full Range)
 85.3 
 (80.7 to 89.9) 
 84.2 
 (77.9 to 90.5) 
 84.8 
 (77.9 to 90.5) 
Fasting insulin (ulU/mL) 
[Units: ulU/mL]
Mean (Full Range)
 9.4 
 (6.7 to 13.1) 
 6.8 
 (5.0 to 9.4) 
 8.1 
 (5.0 to 13.1) 
Area under the curve (AUC) glucose (mg*min/dL) 
[Units: mg*min/dL]
Mean (Full Range)
 16447 
 (15390 to 17504) 
 13168 
 (12209 to 14127) 
 14808 
 (12209 to 17504) 
AUC insulin (mg*min/ml) 
[Units: Mg*min/ml]
Mean (Full Range)
 8351 
 (4788 to 14568) 
 5284 
 (3127 to 8929) 
 6818 
 (3127 to 14568) 
Whole Body Insulin Sensitivity Index 
[Units: Units on a scale]
Mean (Full Range)
 4.76 
 (2.40 to 7.11) 
 6.90 
 (4.87 to 8.93) 
 5.83 
 (2.40 to 8.93) 
Plasma DCI (nmol/mL) 
[Units: nmol/mL]
Mean (Full Range)
 0.36 
 (0.18 to 0.72) 
 0.33 
 (0.18 to 0.63) 
 0.35 
 (0.18 to 0.72) 
24-h urinary D-chiroinositol (DCI) (nmol/day) 
[Units: Nmol/day]
Mean (Full Range)
 1808 
 (927 to 3527) 
 1448 
 (771 to 2719) 
 1628 
 (771 to 3527) 
Urinary clearance (uCl) DCI (ml/min) 
[Units: Ml/min]
Mean (Full Range)
 3.46 
 (1.51 to 7.92) 
 3.02 
 (1.38 to 6.59) 
 3.24 
 (1.38 to 7.92) 
Plasma myo-Inositol (MYO) (nmol/mL) 
[Units: nmol/mL]
Mean (Full Range)
 19.7 
 (15.9 to 23.4) 
 23.1 
 (18.9 to 27.3) 
 21.4 
 (15.9 to 27.3) 
24-h urinary MYO (nmol/day) 
[Units: Nmol/day]
Mean (Full Range)
 52866 
 (32681 to 85519) 
 78909 
 (50140 to 124184) 
 65888 
 (32681 to 124184) 
uCI MYO (ml/min) 
[Units: Ml/min]
Mean (Full Range)
 1.91 
 (1.30 to 2.81) 
 2.43 
 (1.69 to 3.49) 
 2.17 
 (1.30 to 3.49) 


  Outcome Measures

1.  Primary:   Renal Clearance of D-chiroinositol (DCI) at 12 Days   [ Time Frame: 12 days ]

2.  Primary:   Level of Circulating D-chiro Inositol (DCI)   [ Time Frame: 12 days ]


  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
No text entered.


  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: jnestler@mcvh-vcu.edu



Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00683774     History of Changes
Other Study ID Numbers: VCU IRB 4479
2R01HD035629-09A2 ( U.S. NIH Grant/Contract )
First Submitted: May 21, 2008
First Posted: May 23, 2008
Results First Submitted: May 30, 2014
Results First Posted: August 21, 2014
Last Update Posted: June 14, 2017