Clinical trial · Interventional
Liver and Fat Regulation in Overweight Adolescent Girls
Assessment of Hepatic Glucose and Fat Regulation in Overweight Adolescent Girls
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Steatosis | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Byetta 5Mcg Pen Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- PCOS, medication naive + Byetta
- description
- PCOS, medication naive; 10 girls with PCOS will receive 2 doses of Byetta.
- interventionNames
- Drug: Byetta 5Mcg Pen Injection
- type
- NO_INTERVENTION
- label
- Control
- description
- Up to 25 girls without PCOS
- type
- NO_INTERVENTION
- label
- PCOS medication naive
- description
- Up to 45 girls with PCOS with no exposure to hormone therapy or metformin in the preceding 6 months.
- type
- NO_INTERVENTION
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 12 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDBoster 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 42014131
- DERIVEDCarreau 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 31301251
- DERIVEDSimon 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 30888398