Trial Outcomes & Findings for Insulin and Polycystic Ovary Syndrome (NCT NCT00683774)

NCT ID: NCT00683774

Last Updated: 2017-06-14

Results Overview

Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 12 days
• Results posted on: 2017-06-14

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	11	10
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by Subject	0	1
Overall Study Physician Decision	3	0

Baseline Characteristics

Insulin and Polycystic Ovary Syndrome

Baseline characteristics by cohort

Measure	PCOS Subjects n=8 Participants PCOS subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days	Normal Subjects n=9 Participants Normal subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
BMI (Body Mass Index)	41.0 kg/m^2 n=5 Participants	38.4 kg/m^2 n=7 Participants	39.7 kg/m^2 n=5 Participants
Waist-to-hip ratio (WHR)	0.84 unitless n=5 Participants	0.78 unitless n=7 Participants	0.81 unitless n=5 Participants
Sex hormone binding globulin (SHBG) (nmol/L)	32.1 nmol/L n=5 Participants	45.6 nmol/L n=7 Participants	38.9 nmol/L n=5 Participants
Total testosterone (ng/mL)	2.2 ng/mL n=5 Participants	1.1 ng/mL n=7 Participants	1.7 ng/mL n=5 Participants
Free testosterone (pmol/L)	144.3 pmol/L n=5 Participants	57.7 pmol/L n=7 Participants	101 pmol/L n=5 Participants
Fasting glucose (mg/dl)	85.3 mg/dl n=5 Participants	84.2 mg/dl n=7 Participants	84.8 mg/dl n=5 Participants
Fasting insulin (ulU/mL)	9.4 ulU/mL n=5 Participants	6.8 ulU/mL n=7 Participants	8.1 ulU/mL n=5 Participants
Area under the curve (AUC) glucose (mg*min/dL)	16447 mg*min/dL n=5 Participants	13168 mg*min/dL n=7 Participants	14808 mg*min/dL n=5 Participants
AUC insulin (mg*min/ml)	8351 mg*min/ml n=5 Participants	5284 mg*min/ml n=7 Participants	6818 mg*min/ml n=5 Participants
Whole Body Insulin Sensitivity Index	4.76 units on a scale n=5 Participants	6.90 units on a scale n=7 Participants	5.83 units on a scale n=5 Participants
Plasma DCI (nmol/mL)	0.36 nmol/mL n=5 Participants	0.33 nmol/mL n=7 Participants	0.35 nmol/mL n=5 Participants
24-h urinary D-chiroinositol (DCI) (nmol/day)	1808 nmol/day n=5 Participants	1448 nmol/day n=7 Participants	1628 nmol/day n=5 Participants
Urinary clearance (uCl) DCI (ml/min)	3.46 ml/min n=5 Participants	3.02 ml/min n=7 Participants	3.24 ml/min n=5 Participants
Plasma myo-Inositol (MYO) (nmol/mL)	19.7 nmol/mL n=5 Participants	23.1 nmol/mL n=7 Participants	21.4 nmol/mL n=5 Participants
24-h urinary MYO (nmol/day)	52866 nmol/day n=5 Participants	78909 nmol/day n=7 Participants	65888 nmol/day n=5 Participants
uCI MYO (ml/min)	1.91 ml/min n=5 Participants	2.43 ml/min n=7 Participants	2.17 ml/min n=5 Participants

PRIMARY outcome

Timeframe: 12 days

Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay

Outcome measures

Measure	PCOS Subjects n=8 Participants PCOS subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days	Normal Subjects n=9 Participants Normal subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days
Renal Clearance of D-chiroinositol (DCI) at 12 Days	4.75 ml/min Interval 2.25 to 10.01	5.16 ml/min Interval 2.55 to 10.42

PRIMARY outcome

Timeframe: 12 days

Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide

Outcome measures

Measure	PCOS Subjects n=8 Participants PCOS subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days	Normal Subjects n=9 Participants Normal subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days
Level of Circulating D-chiro Inositol (DCI)	0.27 nmol/mL Interval 0.12 to 0.57	0.27 nmol/mL Interval 0.13 to 0.56

Adverse Events

PCOS Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Nestler

Virginia Commonwealth University

Phone: 804-828-3389

Email: jnestler@mcvh-vcu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place