Liver and Fat Regulation in Overweight Adolescent Girls
APPLE
Assessment of Hepatic Glucose and Fat Regulation in Overweight Adolescent Girls
3 other identifiers
interventional
92
1 country
1
Brief Summary
Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis compared to weight similar women with regular menses. It is unclear if this is related to high testosterone or insulin resistance. The investigators will assess hepatic glucose release, rates of lipolysis and hepatic de novo lipogenesis in the fasted and postprandial state to determine if alterations in the processes contribute to hepatic steatosis. Participants will be overweight, sedentary girls with or without PCOS. Those with PCOS will either be medication naive, or must be taking metformin or combined oral contraceptives (COCPs) for a period of at least 6 months prior to study procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2014
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedResults Posted
Study results publicly available
June 4, 2024
CompletedJune 4, 2024
May 1, 2024
8.3 years
June 4, 2014
April 15, 2024
May 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Hepatic Glucose Release
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
Measured up to 4 months from enrollment
Secondary Outcomes (4)
Hepatic Phosphate Concentrations
Measured up to 4 months from enrollment
Rates of Lipolysis
Measured up to 4 months from enrollment
Hepatic Fat Fraction
Measured up to 4 months from enrollment
Hepatic de Novo Lipogenesis
Measured up to 4 months from enrollment
Other Outcomes (3)
Whole Body Insulin Sensitivity
Measured up to 4 months from enrollment
Sleep Quality
Measured up to 4 months from enrollment
Sleep Duration
Measured up to 4 months from enrollment
Study Arms (5)
PCOS, medication naive + Byetta
EXPERIMENTALPCOS, medication naive; 10 girls with PCOS will receive 2 doses of Byetta.
Control
NO INTERVENTIONUp to 25 girls without PCOS
PCOS medication naive
NO INTERVENTIONUp to 45 girls with PCOS with no exposure to hormone therapy or metformin in the preceding 6 months.
PCOS on COCPs
NO INTERVENTIONUp to 10 girls with PCOS and 6 months of therapy with combined oral contraceptives (COCPs) prior to study procedures.
PCOS on metformin
NO INTERVENTIONUp to 10 girls with PCOS and 6 months of therapy with metformin prior to study procedures
Interventions
10 participants will receive 2 doses of Byetta, one at 7 PM the night prior to metabolic study and the second 30 min before ingestion of glucola
Eligibility Criteria
You may qualify if:
- Females
- years post-menarche
- BMI percentile \>90%
You may not qualify if:
- Type 2 diabetes
- Anemia
- Liver disease
- Medications known to effect insulin sensitivity
- Cause of oligomenorrhea or hirsutism other than PCOS,
- \>3 hours a week of moderate exercise.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anshutz Medical Campus/Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Related Publications (2)
Carreau AM, Pyle L, Garcia-Reyes Y, Rahat H, Vigers T, Jensen T, Scherzinger A, Nadeau KJ, Cree-Green M. Clinical prediction score of nonalcoholic fatty liver disease in adolescent girls with polycystic ovary syndrome (PCOS-HS index). Clin Endocrinol (Oxf). 2019 Oct;91(4):544-552. doi: 10.1111/cen.14062. Epub 2019 Aug 16.
PMID: 31301251DERIVEDSimon SL, McWhirter L, Diniz Behn C, Bubar KM, Kaar JL, Pyle L, Rahat H, Garcia-Reyes Y, Carreau AM, Wright KP, Nadeau KJ, Cree-Green M. Morning Circadian Misalignment Is Associated With Insulin Resistance in Girls With Obesity and Polycystic Ovarian Syndrome. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3525-3534. doi: 10.1210/jc.2018-02385.
PMID: 30888398DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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.
Results Point of Contact
- Title
- Melanie Cree-Green, PI
- Organization
- University of Colorado Anschutz Medical Campus
Study Officials
- PRINCIPAL INVESTIGATOR
Melanie Cree Green, MD, PhD
Department of Endocrinology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2014
First Posted
June 6, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
June 4, 2024
Results First Posted
June 4, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
Data will only be shared with IRB approved personnel.