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Clinical Trial NCT07169136 for Polycystic Ovarian Syndrome in Adolescent Females, Obesity (Disorder) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS) 20 Adolescent Lifestyle Dietary Exercise-Based
Clinical Trial NCT07169136 is an observational study for Polycystic Ovarian Syndrome in Adolescent Females, Obesity (Disorder) that is recruiting. It started on September 11, 2025 with plans to enroll 20 participants. Led by Nemours Children's Clinic, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on September 16, 2025.
Brief Summary
The prevalence of childhood obesity in the United States has more than tripled in the past four decades affecting one in every five adolescent girls and is disproportionally higher among racial and/or ethnic minorities. Normal puberty onset and progression is dependent on normal hypothalamic-pituitary-gonadal (HPG) axis which is affected by whole body metabolism. Gonadotropin-releasing hormone (GnRH) and gonadotropin...Show More
Detailed Description
The prevalence of childhood obesity in the United States has more than tripled in the past four decades affecting one in every five adolescent girls and is disproportionally higher among racial and/or ethnic minorities. Normal puberty onset and progression is dependent on normal hypothalamic-pituitary-gonadal (HPG) axis which is affected by whole body metabolism. Gonadotropin-releasing hormone (GnRH) and gonadotropin...Show More
Official Title
Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)
Conditions
Polycystic Ovarian Syndrome in Adolescent FemalesObesity (Disorder)Publications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 25-014
NCT ID Number
Start Date (Actual)
2025-09-11
Last Update Posted
2025-09-16
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
20
Study Type
Observational
Status
Recruiting
Keywords
PCOS
Obesity
Adolescent Female
irregular menstrual cycles
Obesity
Adolescent Female
irregular menstrual cycles
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Females ages 12 to 18 years, at least 2 years post-menarche, with obesity and PCOS.. Females ages 12 to 18 years, at least 2 years post-menarche, with obesity (BMI equal to or more than the 95th percentile for age) and with PCOS, by NIH criteria: oligomenorrhea (menstrual cycles \<21 or \>35 days) \[4\] and hyperandrogenism (testosterone level or free androgen index (FAI) \> refence range for tanner stage) and in good overall health. FAI is calculated as total testosterone\*100/sex hormone binding gl...Show More | GLP-1 Receptor Agonists Weekly subcutaneous Semaglutide. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in LH pulse frequency after 4 months of GLP-1 agonist use. | LH will be obtained every 20 minutes overnight. LH will be measured using a chemiluminescence assay. Pulse frequency will be calculated using mathematical deconvolution analysis. | Blood sampling will occur at study enrollment and then 4 months post intervention. |
Change in average levels of LH and FSH after 4 months of GLP-1 agonist use. | LH and FSH will be measured using a chemiluminescence assay. | Blood sampling will occur at study enrollment and then 4 months post intervention. |
Change in average levels of Total testosterone and Estradiol after 4 months of GLP-1 agonist use. | Total testosterone and estradiol will be measured by liquid chromatography-mass spectrometry | Blood sampling will occur at study enrollment and then 4 months post intervention. |
Change in average levels of progesterone after 4 months of GLP-1 agonist use. | Progesterone will be measured using immunoassay. | Blood sampling will occur at study enrollment and then 4 months post intervention. |
Change in LH amplitude. | LH will be obtained every 20 minutes overnight. LH will be measured using a chemiluminescence assay. Pulse amplitude will be calculated using mathematical deconvolution analysis. | Blood sampling will occur at study enrollment and then 4 months post intervention. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Body composition will be measured by dual x-ray absorptiometry (DXA) scan. | Body composition will be measured by DEXA (Hologic Discovery A) | At enrollment and 4 months post intervention. |
Carbohydrate metabolism and insulin sensitivity will be analyzed. | Carbohydrate metabolism and insulin sensitivity will be measured by HOMA-IR (using fasting insulin and glucose levels). | Sampling will occur at enrollement and 4 months post intervention. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
12 Years
Eligible Sexes
Female
- Diagnosed with PCOS, by NIH criteria: oligomenorrhea (menstrual cycles <21 or >35 days) and hyperandrogenism (testosterone level or free androgen index (FAI) > refence range for tanner stage) and in good overall health
- Obesity (equal to or more than the 95th percentile)
- Females ages 12 to 18 years, at least 2 years post-menarche
- Participants has persistent symptoms of PCOS and obesity despite lifestyle modifications for at least 4 months.
- Has abnormal thyroid function tests at Screening.
- Has suspected or known Diabetes mellitus, impaired fasting glucose, or elevated hemoglobin A1c.
- Has non-classic congenital adrenal hyperplasia.
- Has hyperprolactinemia.
- Has a known history or family history of medullary thyroid carcinoma or MEN2 and history of pancreatitis
- Participants receiving prior treatment with metformin, GLP-1 agonists, oral contraception pills, progesterone, or other insulin sensitizers for at least 6 weeks prior to Screening.
- Is currently pregnant or has been pregnant.
Nemours Children's ClinicStudy Responsible Party
Camila Pereira-Eshraghi, Principal Investigator, MD., Nemours Children's Clinic
Study Central Contact
Contact: Camila Pereira-Eshraghi, MD. MS., 1 + 904-408-7895, [email protected]
1 Study Locations in 1 Countries
Florida
Nemours Children's Clinic, Jacksonville, Florida, 32207, United States
Camila Pereira-Eshraghi, MD. MS., Contact, 1 + 904-408-7895, [email protected]
Recruiting