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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
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PCOS Subjects Normal Subjects
Hide Arm/Group Description

PCOS subjects given diazoxide

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

Normal subjects given diazoxide

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

Period Title: Overall Study
Started 11 10
Completed 8 9
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             0             1
Physician Decision             3             0
Arm/Group Title PCOS Subjects Normal Subjects Total
Hide Arm/Group Description

PCOS subjects given diazoxide

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

Normal subjects given diazoxide

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

Total of all reporting groups
Overall Number of Baseline Participants 8 9 17
Hide Baseline Analysis Population Description
Obese women with and without PCOS between the ages of 18-40 years selected after examination and eligibility screening
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Female
8
 100.0%
9
 100.0%
17
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 9 participants 17 participants
8 9 17
BMI (Body Mass Index)  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 8 participants 9 participants 17 participants
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)  
Mean (Full Range)
Unit of measure:  Unitless
Number Analyzed 8 participants 9 participants 17 participants
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)  
Mean (Full Range)
Unit of measure:  nmol/L
Number Analyzed 8 participants 9 participants 17 participants
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)  
Mean (Full Range)
Unit of measure:  ng/mL
Number Analyzed 8 participants 9 participants 17 participants
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)  
Mean (Full Range)
Unit of measure:  pmol/L
Number Analyzed 8 participants 9 participants 17 participants
144.3
(73.1 to 285.1)
57.7
(30.4 to 109.6)
101
(30.4 to 285.1)
Fasting glucose (mg/dl)  
Mean (Full Range)
Unit of measure:  Mg/dl
Number Analyzed 8 participants 9 participants 17 participants
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)  
Mean (Full Range)
Unit of measure:  ulU/mL
Number Analyzed 8 participants 9 participants 17 participants
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)  
Mean (Full Range)
Unit of measure:  mg*min/dL
Number Analyzed 8 participants 9 participants 17 participants
16447
(15390 to 17504)
13168
(12209 to 14127)
14808
(12209 to 17504)
AUC insulin (mg*min/ml)  
Mean (Full Range)
Unit of measure:  Mg*min/ml
Number Analyzed 8 participants 9 participants 17 participants
8351
(4788 to 14568)
5284
(3127 to 8929)
6818
(3127 to 14568)
Whole Body Insulin Sensitivity Index  
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 9 participants 17 participants
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)  
Mean (Full Range)
Unit of measure:  nmol/mL
Number Analyzed 8 participants 9 participants 17 participants
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)  
Mean (Full Range)
Unit of measure:  Nmol/day
Number Analyzed 8 participants 9 participants 17 participants
1808
(927 to 3527)
1448
(771 to 2719)
1628
(771 to 3527)
Urinary clearance (uCl) DCI (ml/min)  
Mean (Full Range)
Unit of measure:  Ml/min
Number Analyzed 8 participants 9 participants 17 participants
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)  
Mean (Full Range)
Unit of measure:  nmol/mL
Number Analyzed 8 participants 9 participants 17 participants
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)  
Mean (Full Range)
Unit of measure:  Nmol/day
Number Analyzed 8 participants 9 participants 17 participants
52866
(32681 to 85519)
78909
(50140 to 124184)
65888
(32681 to 124184)
uCI MYO (ml/min)  
Mean (Full Range)
Unit of measure:  Ml/min
Number Analyzed 8 participants 9 participants 17 participants
1.91
(1.30 to 2.81)
2.43
(1.69 to 3.49)
2.17
(1.30 to 3.49)
1.Primary Outcome
Title Renal Clearance of D-chiroinositol (DCI) at 12 Days
Hide Description Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay
Time Frame 12 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PCOS Subjects Normal Subjects
Hide Arm/Group Description:

PCOS subjects given diazoxide

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

Normal subjects given diazoxide

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

Overall Number of Participants Analyzed 8 9
Mean (Full Range)
Unit of Measure: ml/min
4.75
(2.25 to 10.01)
5.16
(2.55 to 10.42)
2.Primary Outcome
Title Level of Circulating D-chiro Inositol (DCI)
Hide Description Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide
Time Frame 12 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PCOS Subjects Normal Subjects
Hide Arm/Group Description:

PCOS subjects given diazoxide

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

Normal subjects given diazoxide

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

Overall Number of Participants Analyzed 8 9
Mean (Full Range)
Unit of Measure: nmol/mL
0.27
(0.12 to 0.57)
0.27
(0.13 to 0.56)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PCOS Subjects Normal Subjects
Hide Arm/Group Description

PCOS subjects given diazoxide

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

Normal subjects given diazoxide

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

All-Cause Mortality
PCOS Subjects Normal Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PCOS Subjects Normal Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PCOS Subjects Normal Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
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: 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