Trial Outcomes & Findings for Post-Prandial Liver Glucose Metabolism in PCOS (NCT NCT03041129)
NCT ID: NCT03041129
Last Updated: 2024-04-17
Results Overview
Amount of fat in the liver measured by MRI and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%. Greater than 5% is considered extra fat in the liver.
Recruitment status
COMPLETED
Target enrollment
19 participants
Primary outcome timeframe
Measured up to 4 months from enrollment
Results posted on
2024-04-17
Participant Flow
Participant milestones
| Measure |
Untreated PCOS
PCOS per NIH criteria. Obese Lifestyle treatment only.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Metformin PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Oral Contraceptive PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Obese Control Group-(Study Arm Not Funded)
Obese Regular menses at least 18 months post-menarche Females only
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
17
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Untreated PCOS
PCOS per NIH criteria. Obese Lifestyle treatment only.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Metformin PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Oral Contraceptive PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Obese Control Group-(Study Arm Not Funded)
Obese Regular menses at least 18 months post-menarche Females only
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Post-Prandial Liver Glucose Metabolism in PCOS
Baseline characteristics by cohort
| Measure |
Untreated PCOS
n=17 Participants
PCOS per NIH criteria. Obese Lifestyle treatment only.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Metformin PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Oral Contraceptive PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Obese Control Group-(Study Arm Not Funded)
Obese Regular menses at least 18 months post-menarche Females only
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
16.2 years
STANDARD_DEVIATION 1.68 • n=5 Participants
|
—
|
—
|
—
|
16.2 years
STANDARD_DEVIATION 1.68 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
—
|
—
|
—
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
—
|
—
|
—
|
17 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured up to 4 months from enrollmentPopulation: Adolescent females with dx of PCOS
Amount of fat in the liver measured by MRI and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%. Greater than 5% is considered extra fat in the liver.
Outcome measures
| Measure |
Untreated PCOS
n=17 Participants
PCOS per NIH criteria. Obese Lifestyle treatment only.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Metformin PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Oral Contraceptive PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Obese Control Group-(Study Arm Not Funded)
Obese Regular menses at least 18 months post-menarche Females only
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
|---|---|---|---|---|
|
Hepatic Fat Fraction
|
8.35 Percent
Standard Deviation 7.55
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured up to 4 months from enrollmentPopulation: Adolescent females with diagnosis of PCOS
Percent indirect glucose at 360 minutes following an oral sugar tolerance test (OGTT) with an isotope labeled oral glycerol tracer.
Outcome measures
| Measure |
Untreated PCOS
n=16 Participants
PCOS per NIH criteria. Obese Lifestyle treatment only.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Metformin PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Oral Contraceptive PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Obese Control Group-(Study Arm Not Funded)
Obese Regular menses at least 18 months post-menarche Females only
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
|---|---|---|---|---|
|
Hepatic Metabolism Ratios
|
22.1 percentage of indirect glucose
Standard Deviation 6.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured up to 4 months from enrollmentPopulation: Adolescent females with dx of PCOS
Participants will undergo a 75 gram oral glucose tolerance test, and whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model.
Outcome measures
| Measure |
Untreated PCOS
n=17 Participants
PCOS per NIH criteria. Obese Lifestyle treatment only.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Metformin PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Oral Contraceptive PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Obese Control Group-(Study Arm Not Funded)
Obese Regular menses at least 18 months post-menarche Females only
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
|---|---|---|---|---|
|
Whole Body Insulin Sensitivity
|
0.000278106 dL/kg/min per uU/mL
Standard Deviation 0.000393419
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured up to 4 months from enrollmentPopulation: Adolescent females with dx of PCOS
Sleep duration will be assessed using home actigraphy using the Philips Actigraph wrist-worn watch, and collects 7 days of data.
Outcome measures
| Measure |
Untreated PCOS
n=14 Participants
PCOS per NIH criteria. Obese Lifestyle treatment only.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Metformin PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Oral Contraceptive PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Obese Control Group-(Study Arm Not Funded)
Obese Regular menses at least 18 months post-menarche Females only
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
|---|---|---|---|---|
|
Sleep Duration
|
443.44 Minutes
Standard Deviation 52.63
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured up to 4 months from enrollmentPopulation: Adolescent females with dx of PCOS
Apnea Hypopnea Index (AHI) will be measured using WatchPAT. The higher the AHI, indicates more severe sleep apnea. The AHI is the number of times you have apnea or hypopnea during one night, divided by the hours of sleep. Normal sleep: An AHI of fewer than five events, on average, per hour Mild sleep apnea: An AHI of five to 14 events per hour Moderate sleep apnea: An AHI of 15 to 29 events per hour Severe sleep apnea: An AHI of 30 or more events per hour
Outcome measures
| Measure |
Untreated PCOS
n=17 Participants
PCOS per NIH criteria. Obese Lifestyle treatment only.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Metformin PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Oral Contraceptive PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Obese Control Group-(Study Arm Not Funded)
Obese Regular menses at least 18 months post-menarche Females only
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
|---|---|---|---|---|
|
Sleep Quality
|
19.66 Apnea Hypoxia Index
Standard Deviation 10.82
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured up to 4 months from enrollmentPopulation: Untreated PCOS, All participants whom the scan worked for. Did not work in those with a large waist circumference
31 phosphorus spectroscopy will be utilized to measure hepatic Phosphodiesterase (PDE)/Total phosphate concentration. This is measured in the MRI using a phosphorus coil.
Outcome measures
| Measure |
Untreated PCOS
n=15 Participants
PCOS per NIH criteria. Obese Lifestyle treatment only.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Metformin PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 1500 mg of metformin or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Oral Contraceptive PCOS-(Study Arm Not Funded)
PCOS per NIH criteria. Obese Taking 30 mcg of ethanyl estradiol or more per day for at least 6 months.
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
Obese Control Group-(Study Arm Not Funded)
Obese Regular menses at least 18 months post-menarche Females only
oral glucose tolerance test: 6 hours OGTT
MRI of liver: MRI of the liver and use of DIXON method
|
|---|---|---|---|---|
|
Hepatic Phosphate Concentrations
|
23 percentage of PDE/total phosphate
Standard Deviation 7
|
—
|
—
|
—
|
Adverse Events
Untreated PCOS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Metformin PCOS-(Study Arm Not Funded)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Contraceptive PCOS-(Study Arm Not Funded)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese Control Group-(Study Arm Not Funded)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place