Investigating liver fat in adolescents and young adults with PCOS
Nonalcoholic Fatty Liver Disease (NAFLD), Insulin Resistance and Dyslipidemia in Adolescents and Young Adults With Polycystic Ovary Syndrome (PCOS)
This study looks at whether young people with Polycystic Ovary Syndrome (PCOS) have more liver fat than those without PCOS to understand potential health risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 14 Years to 25 Years |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02506946 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence of elevated liver fat in adolescents and young adults diagnosed with Polycystic Ovary Syndrome (PCOS) compared to age-matched controls. It will utilize advanced non-invasive techniques such as magnetic resonance spectroscopy (MRS) and MRI to measure liver fat deposition and assess metabolic disturbances. The study will include 40 participants with PCOS and 40 healthy controls, focusing on the relationship between liver fat, insulin resistance, dyslipidemia, and body composition. The findings could provide insights into the long-term health risks associated with PCOS in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adolescents and young adults aged 14 to 25 years, with a diagnosis of PCOS or regular menstrual cycles as controls.
Not a fit: Patients with a history of medical disorders affecting body composition or those currently using hormonal contraceptives or medications like metformin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early detection and management of liver-related health issues in adolescents and young adults with PCOS.
How similar studies have performed: While studies have explored the relationship between PCOS and metabolic disturbances, this specific focus on liver fat in adolescents is relatively novel and under-researched.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All: Healthy; between 14 and 25 years; at least 2 years postmenarche * PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the NIH 1990 criteria. * Controls: Regular menses; no clinical hyperandrogenism and/or hyperandrogenemia Exclusion Criteria: * Past or present history of a medical disorder or medication known to affect body composition, insulin secretion and sensitivity, or the growth hormone (GH)-insulin-like growth factor 1 (IGF1) axis (eg steroid hormone or thyroid replacement). * History of current or past pregnancy * Hormonal contraceptive or metformin use within 3 months of enrollment * Nonclassical congenital adrenal hyperplasia
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Aviva Sopher, MD, MS, MS — Columbia University
- Study coordinator: Aviva B Sopher, MD, MS, MS
- Email: ahs32@cumc.columbia.edu
- Phone: 212-305-6559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.