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Investigating the Impact of Obesity on Pubertal Development in Girls

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 28, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

The 50 most recent of 270 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor New version filed on ClinicalTrials.gov
  3. Minor Enrollment closed, study ongoing
    • Final enrollment: 93 participants (planned 150)
    v268
  4. Minor 20 versions Re-verified since Nov 29, 2025, no change to tracked fieldsv248-v267
  5. Notable Primary and study completion dates: Sep 30, 2025 to Sep 30, 2026v247
  6. Minor 26 versions Re-verified since Oct 25, 2024, no change to tracked fieldsv221-v246
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Studies suggest that overweight girls may be developing breast tissue, and therefore starting puberty, earlier than normal weight girls. However, it is hard to distinguish breast tissue from fatty tissue. Researchers think that by using breast ultrasound, among other tests, they can do a better job of telling whether an overweight girl has breast tissue. This will help them understand if overweight girls are truly entering puberty before normal weight girls. Objective: To find out if overweight girls go through puberty earlier than normal weight girls. Eligibility: Healthy girls 8-14 years old who: * Are normal weight or overweight * Have some breast development * Have not started their first period Design: Parents of participants will be screened over the phone. Most participants will have 1 visit. However, they can choose to have multiple visits within 4 weeks. The visit will include: * Physical exam that includes examination of the breasts and genital area * Breast ultrasound: A small hand-held device will be passed back and forth over the chest. It uses sound waves to create a picture of the breast tissue. * Pelvic ultrasound: A small, handheld device will be passed back and forth over the lower belly. It uses sound waves to create a picture of the ovaries. * Urine and blood test * A special x-ray called a DXA to measure the amount of fat in the body: The participant will lie still on a table while the x-ray takes pictures of the body. X-ray of the hand: The picture will tell researchers how mature the participant s bones are. Participants may be asked to come back 6 months later to repeat these tests.
Trial Details
NCT Number NCT02583646
Lead Sponsor National Institute of Environmental Health Sciences (NIEHS)
Conditions
(from sponsor)
Obesity, Puberty, Normal Physiology
Related terms Obesity
Enrollment 93 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov