DRUG
Byetta 5Mcg Pen Injection
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
Liver and Fat Regulation in Overweight Adolescent Girls
Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
92
Locations
1
Results
Posted
Publications
3
Study summary
What the protocol is testing.
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.
Full detailed description
Hepatic glucose release will be assessed with a stable isotope glycerol tracer, lipolysis with a glycerol tracer, and hepatic de novo lipogenesis with an acetate tracer. Data will be collected fasting and after a glucose challenge. The degree of hepatic steatosis and abdominal fat partitioning will be assessed with Magnetic Resonance Imaging (MRI), and total body composition with Dual-energy X-ray absorptiometry (DEXA).
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 6, 2014
Study start
Aug 2014
Primary completion
Dec 2022
Study completion
Dec 2022
Results posted
Jun 4, 2024
Registry updated
Jun 4, 2024
Outcomes
What the study measures.
Primary outcomes
Hepatic Glucose Release
Time frame · 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 outcomes
Hepatic Phosphate Concentrations
Time frame · 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)
Rates of Lipolysis
Time frame · 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.
Hepatic Fat Fraction
Time frame · 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.
Hepatic de Novo Lipogenesis
Time frame · 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.
Eligibility
Who can take part.
- Minimum age
- 12 Years
- Maximum age
- 21 Years
- Sex
- FEMALE
- Healthy volunteers
- Yes
Inclusion Criteria: * Females * 2 years post-menarche * BMI percentile \>90% Exclusion Criteria: * 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.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Colorado Anshutz Medical Campus/Children's Hospital Colorado
Aurora, Colorado, United States
Publications
Results and literature.
PMID 42014131 ↗Boster JM, Cree MG, Kelsey MM, Nadeau KJ, Chaidez A, Pan Z, Sundaram SS. Relative Skeletal Muscle Mass Is Associated With Hepatic Steatosis in Adolescents With Overweight and Obesity. Pediatr Obes. 2026 Apr;21(4):e70108. doi: 10.1111/ijpo.70108.PMID 31301251 ↗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 30888398 ↗Simon 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.
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