Phase 3
N=92
Liver and Fat Regulation in Overweight Adolescent Girls
Hepatic Steatosis · Polycystic Ovarian Syndrome · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02157974 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Hepatic Glucose Release — 1.85; 1.46; 1.54; 1.88 mg/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Byetta 5Mcg Pen Injection (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hepatic Glucose Release |
1.85; 1.46; 1.54; 1.88; 1.57 | — |
| SECONDARY Hepatic Phosphate Concentrations |
0.167684728; 0.198640255; 0.198787476; 0.186923469; 0.067905319; 0.077949656 | — |
| SECONDARY Rates of Lipolysis |
0.54; 0.49; 0.49; 0.78; 0.65 | — |
| SECONDARY Hepatic Fat Fraction |
4.1; 7.6; 6.9; 6.8; 13.3 | — |
| SECONDARY Hepatic de Novo Lipogenesis |
9.3; 6.6; 7.9; 18.2; 19.4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02157974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.