Trial · NCT02157974

Liver and Fat Regulation in Overweight Adolescent Girls

NCT02157974, Phase 2, Phase 3, Completed, University of Colorado, Denver; results first posted 2024-06-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Liver and Fat Regulation in Overweight Adolescent Girls. Trials, record NCT02157974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02157974

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Liver and Fat Regulation in Overweight Adolescent Girls
NCT number: NCT02157974
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 92 participants, actual
Lead sponsor: University of Colorado, Denver
Conditions: Hepatic Steatosis, Polycystic Ovarian Syndrome, Obesity
Interventions: Byetta 5Mcg Pen Injection
First posted: 2014-06-06
Last updated: 2024-06-04
Results first posted: 2024-06-04
Limitations and caveats: Due to the Covid-19 outbreak, we were unable to enroll the last 4 participants in the PCOS on metformin arm, so the results may not reach statistical significance. We had delays in getting tracer results due to the mass spec machine being down, and once raw data was obtained, we needed to work with a mathematician to calculate the rates of appearance of the tracer results.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hepatic Glucose Release	Measured up to 4 months from enrollment	Hepatic glucose release will be measured by the rate of appearance of a glucose tracer. Glucose rate of appearance reflects the amount of glucose being release by primarily the liver during fasting. A higher glucose rate of appearance is often seen with dysglycemia
Secondary	Hepatic Phosphate Concentrations	Measured up to 4 months from enrollment	Hepatic phosphate relative concentrations will be measured with 31 phosphorus magnetic resonance spectroscopy. The ratio of the following will be reported over total phosphate concentration: Phosphodiesterase (PDE), phosphomonoester (PME), Adenosine triphosphate (ATP), Inorganic Phosphate (Pi),Nicotinamide adenine dinucleotide phosphate (NADPH), Uridine diphosphate glucose (UDPG)
Secondary	Rates of Lipolysis	Measured up to 4 months from enrollment	Rate of lipolysis will be measured by the rate of appearance of a glycerol tracer. Glycerol rate of appearance reflects the amount of glycerol being released into the blood stream as a results of lipolysis. Higher rates of lipolysis are thought to be associated with insulin resistance.
Secondary	Hepatic Fat Fraction	Measured up to 4 months from enrollment	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.
Secondary	Hepatic de Novo Lipogenesis	Measured up to 4 months from enrollment	Hepatic de novo lipogenesis will be measured by with an acetate tracer by mass spectroscopy. De novo lipogenesis can contribute to non-alcoholic fatty liver disease, so having a lower value is better.
Other	Whole Body Insulin Sensitivity	Measured up to 4 months from enrollment	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 using SAMM II software. This software uses participant weight, glucose and insulin concentrations at various time points during the oral glucose tolerance test to calculate the participant insulin sensitivity. The higher the Si value means more insulin sensitivity.
Other	Sleep Quality	Measured up to 4 months from enrollment	Apnea Hypopnea Index (AHI) will be measured using WatchPAT. In children and adolescents the scale that will be used is AHI\>5 is considered mild sleep apnea. 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
Other	Sleep Duration	Measured up to 4 months from enrollment	Sleep duration will be assessed using home actigraphy using the Philips Actigraph wrist-worn watch, and collects 7 days of data.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Hepatic Glucose Release	Measured up to 4 months from enrollment	Not all participants had complete data to analyze the glucose RA.	mg/kg/min	MEAN
SECONDARY	Hepatic Phosphate Concentrations	Measured up to 4 months from enrollment	The phosphorus coil for the liver was purchased towards the end of the study, so not all participants had the 31p measured.	ratio over total phosphate	MEAN
SECONDARY	Rates of Lipolysis	Measured up to 4 months from enrollment	Not all participants had complete data to analyze the glycerol RA.	mg/kg/min	MEAN
SECONDARY	Hepatic Fat Fraction	Measured up to 4 months from enrollment	Unable to analyze 2 participants in the PCOS medication naive group. One screen failed and the second who withdrew from the study.	percent fat	MEAN
SECONDARY	Hepatic de Novo Lipogenesis	Measured up to 4 months from enrollment	Not everyone in the study received the acetate tracer. We had a problem with the analysis of the acetate tracer on 3 participants: 1 from the control group and 2 from the metformin group, so we did not obtain data for those 3 participants.	mg/dL	MEAN
OTHER_PRE_SPECIFIED	Whole Body Insulin Sensitivity	Measured up to 4 months from enrollment	We were unable to calculate Si for some of the participants, because we were missing some lab values that are required for the formula.	dL/kg/min/μU/mL	MEAN
OTHER_PRE_SPECIFIED	Sleep Quality	Measured up to 4 months from enrollment	The WatchPAT device was purchased towards the end of the study, so this was only used on a few participants for which results are reported here.	Apnea Hypopnea Index	MEAN
OTHER_PRE_SPECIFIED	Sleep Duration	Measured up to 4 months from enrollment	Watch failed to record data on: 3 participants in the control group, 2 in the PCOS medication naive group, and 1 in the Byetta group. Two participants withdrew from the PCOS medication naive group.	minutes	MEAN

Source ClinicalTrials.gov

Results by group58

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Hepatic Glucose Release	Control		1.85	Standard Deviation 1.24	mg/kg/min
Hepatic Glucose Release	PCOS Medication Naive		1.46	Standard Deviation 0.21	mg/kg/min
Hepatic Glucose Release	PCOS, Medication Naive + Byetta		1.54	Standard Deviation 0.38	mg/kg/min
Hepatic Glucose Release	PCOS on COCPs		1.88	Standard Deviation 0.49	mg/kg/min
Hepatic Glucose Release	PCOS on Metformin		1.57	Standard Deviation 0.07	mg/kg/min
Hepatic Phosphate Concentrations	Control	PDE/TP	0.167684728	Standard Deviation 0.056413082	ratio over total phosphate
Hepatic Phosphate Concentrations	PCOS, Medication Naive + Byetta	PDE/TP	0.198640255	Standard Deviation 0.040933351	ratio over total phosphate
Hepatic Phosphate Concentrations	PCOS on COCPs	PDE/TP	0.198787476	Standard Deviation 0.045832565	ratio over total phosphate
Hepatic Phosphate Concentrations	PCOS on Metformin	PDE/TP	0.186923469	Standard Deviation 0.039481266	ratio over total phosphate
Hepatic Phosphate Concentrations	Control	PME/TP	0.067905319	Standard Deviation 0.033816456	ratio over total phosphate

1 to 10 of 58Source ClinicalTrials.gov

See all 58 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Control	24
Overall Study	STARTED	PCOS Medication Naive	42
Overall Study	STARTED	PCOS, Medication Naive + Byetta	10
Overall Study	STARTED	PCOS on COCPs	10
Overall Study	STARTED	PCOS on Metformin	6
Overall Study	COMPLETED	Control	24
Overall Study	COMPLETED	PCOS Medication Naive	39
Overall Study	COMPLETED	PCOS, Medication Naive + Byetta	10
Overall Study	COMPLETED	PCOS on COCPs	10
Overall Study	COMPLETED	PCOS on Metformin	6

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals15

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Control	24
Total, all-cause mortality	PCOS Medication Naive	42
Total, all-cause mortality	PCOS, Medication Naive + Byetta	10
Total, all-cause mortality	PCOS on COCPs	10
Total, all-cause mortality	PCOS on Metformin	6
Total, other adverse events	Control	24
Total, other adverse events	PCOS Medication Naive	42
Total, other adverse events	PCOS, Medication Naive + Byetta	10
Total, other adverse events	PCOS on COCPs	10
Total, other adverse events	PCOS on Metformin	6

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30888398	DERIVED	PubMed
31301251	DERIVED	PubMed
42014131	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
K23DK107871	Influence of peripheral insulin resistance and hepatic lipogenesis on liver fat in obese PCOS girls	CREE, MELANIE G	UNIVERSITY OF COLORADO DENVER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2015 to 2018	NIH RePORTER
UL1TR001082	Colorado Clinical and Translational Sciences Institute	SOKOL, RONALD J.	UNIVERSITY OF COLORADO DENVER	NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES	2013 to 2017	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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