Abnormal GnRH Pulsatility in Polycystic Ovary Syndrome: Recent Insights.
Christopher R McCartney, Rebecca E Campbell
https://pubmed.ncbi.nlm.nih.gov/32676541Actively Recruiting
Age: 12Years - 18Years
FEMALE
ID07169136
Effects of Glucagon-like Peptide-1 (GLP-1) Agonist on Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)
Led by Nemours Children's Clinic · Updated on 2025-09-16
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to investigate how a GLP-1 receptor agonist affects neuro-reproductive function in obese adolescent females with Polycystic Ovary Syndrome (PCOS). PCOS is a common hormonal disorder affecting females of reproductive age, often linked to obesity and disrupted hormone rhythms. The study focuses on how the GLP-1 hormone, which influences insulin and reproductive hormone release, may impact these neuroendocrine rhythms and metabolism in this group. The study involves up to 20 female adolescents aged 12 to 18 years, who are at least two years post-menarche, have obesity (BMI at or above the 95th percentile), and diagnosed PCOS by NIH criteria. Participants will receive weekly subcutaneous injections of the GLP-1 receptor agonist Semaglutide, alongside lifestyle advice on diet and exercise. Treatment will be titrated to the maximal dose and continue for 16 weeks. Participants will be evaluated before and after treatment with blood tests measuring hormone levels such as LH, FSH, testosterone, estradiol, and progesterone. Body composition will be assessed using dual x-ray absorptiometry (DXA) scans. Carbohydrate metabolism and insulin sensitivity will be analyzed using fasting glucose and insulin levels. The study aims to observe changes in hormone pulse frequency and amplitude, body fat, and metabolism over the 16-week period.
CONDITIONS
Brief Title
Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)
Who Can Participate
Age: 12Years - 18Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female adolescents aged 12 to 18 years
- At least 2 years post-menarche
- Obese with BMI equal to or above the 95th percentile for age
- Diagnosed with PCOS by NIH criteria: oligomenorrhea (menstrual cycles <21 or >35 days) and hyperandrogenism (testosterone level or free androgen index above reference for Tanner stage)
- Persistent PCOS and obesity symptoms despite lifestyle modifications for at least 4 months
- Good overall health
You will not qualify if you...
- Abnormal thyroid function tests at screening
- Known or suspected diabetes mellitus, impaired fasting glucose, or elevated hemoglobin A1c
- Non-classic congenital adrenal hyperplasia
- Hyperprolactinemia
- Known or family history of medullary thyroid carcinoma or MEN2
- History of pancreatitis
- Prior treatment with metformin, GLP-1 agonists, oral contraceptives, progesterone, or other insulin sensitizers within 6 weeks before screening
- Currently pregnant or has been pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 16 weeks
Participants receive weekly subcutaneous injections of a GLP-1 receptor agonist and lifestyle modification advice for diet and exercise.
Weekly visits for medication titration and monitoring
Follow-up
Duration - Up to 1 week after treatment ends
Participants undergo assessments to measure neuroendocrine function, body composition, and carbohydrate metabolism after completing treatment.
1 visit (in-person) for final assessments
Trial Site Locations
Total: 1 location
1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Actively Recruiting
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Research Team
C
Camila Pereira-Eshraghi, MD. MS.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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