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Investigating the Impact of Obesity on Pubertal Development in Girls

NCT02583646 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-05-22

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Natalie D Shaw, M.D. · National Institute of Environmental Health Sciences (NIEHS)

Eligibility

Min Age
8 Years
Max Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-15
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583646 on ClinicalTrials.gov