Investigating the Impact of Obesity on Pubertal Development in Girls
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.
Conditions:
🦠 Obesity 🦠 Puberty 🦠 Normal Physiology
🗓️ Study Start (Actual) 15 December 2015
🗓️ Primary Completion (Estimated) 30 September 2024
✅ Study Completion (Estimated) 30 September 2024
👥 Enrollment (Estimated) 150
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Research Triangle Park, North Carolina, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 8 Years to 14 Years (CHILD)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 October 2015
  • First Submitted that Met QC Criteria 21 October 2015
  • First Posted 22 October 2015

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 July 2024
  • Last Update Posted 26 July 2024
  • Last Verified 23 October 2023