Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man.
D R Matthews, J P Hosker, A S Rudenski...
https://pubmed.ncbi.nlm.nih.gov/3899825/Actively Recruiting
Led by Nemours Children's Clinic · Updated on 2025-09-16
20
Participants Needed
1
Research Sites
N/A
Total Duration
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
Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)
C
Camila Pereira-Eshraghi, MD. MS.
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Nemours Children's Clinic
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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D R Matthews, J P Hosker, A S Rudenski...
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https://pubmed.ncbi.nlm.nih.gov/18957503/Kaitlyn M Ruffing, Kristen J Koltun, Mary Jane De Souza...
https://pubmed.ncbi.nlm.nih.gov/35718216/Christopher R McCartney, Rebecca E Campbell
https://pubmed.ncbi.nlm.nih.gov/32676541/Nemours Children's Clinic
Lead Sponsor