Examining how obesity affects puberty in girls
Investigating the Impact of Obesity on Pubertal Development in Girls
This study is trying to see if overweight girls start puberty earlier than girls who are a normal weight by looking at their breast development and other health factors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 8 Years to 14 Years |
| Sex | Female |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Research Triangle Park, North Carolina) |
| Trial ID | NCT02583646 on ClinicalTrials.gov |
What this trial studies
This observational study investigates whether overweight girls experience earlier onset of puberty compared to their normal weight peers. Researchers will utilize breast ultrasounds and other assessments to differentiate between breast and fatty tissue, aiming to clarify the relationship between obesity and pubertal development. Participants will undergo physical exams, blood draws, and imaging studies to gather comprehensive data on their development. The study focuses on healthy girls aged 8-14 who show some breast development but have not yet started menstruating.
Who should consider this trial
Good fit: Ideal candidates are healthy girls aged 8-14 who are either normal weight or overweight and show some breast development without having started their first period.
Not a fit: Patients who are underweight, have chronic medical conditions, or are currently on medications affecting reproductive hormones may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effects of obesity on pubertal timing, potentially guiding interventions for affected girls.
How similar studies have performed: While there have been studies examining puberty and obesity, this approach using advanced imaging techniques is relatively novel and may provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Girls without a chronic medical condition * Normal weight (BMI 5th-85th%) or overweight/obese (BMI \> 85th%) * 8-14 years old * Some breast development * Pre-menarchal EXCLUSION CRITERIA: * Treated with medications that may affect reproductive hormones (e.g. birth control pills). * Pregnancy During the study, the PI s discretion may be used to determine final eligibility. The PI s discretion may be used at any point in the study (pre-screening, clinical/lab assessments, etc.) to ensure participants are not subjected to unnecessary procedures or visits.
Where this trial is running
Research Triangle Park, North Carolina
- NIEHS, Research Triangle Park — Research Triangle Park, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Natalie D Shaw, M.D. — National Institute of Environmental Health Sciences (NIEHS)
- Study coordinator: NIEHS Join A Study Recruitment Group
- Email: myniehs@nih.gov
- Phone: (855) 696-4347
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.