Phase 3
Completed N=92
Liver and Fat Regulation in Overweight Adolescent Girls
Source: ClinicalTrials.gov NCT02157974 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Hepatic Glucose Release — 1.85; 1.46; 1.54; 1.88 mg/kg/min
◆ Published Evidence
Established
85citations · ~12 / year
Morning Circadian Misalignment Is Associated With Insulin Resistance in Girls With Obesity and Polycystic Ovarian Syndrome.
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.
Linked Publications (3)
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Morning Circadian Misalignment Is Associated With Insulin Resistance in Girls With Obesity and Polycystic Ovarian Syndrome.
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Clinical prediction score of nonalcoholic fatty liver disease in adolescent girls with polycystic ovary syndrome (PCOS-HS index).
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Relative Skeletal Muscle Mass Is Associated With Hepatic Steatosis in Adolescents With Overweight and Obesity.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.