Investigating the Impact of Obesity on Pubertal Development in Girls

Part of paid clinical trials in Research Triangle Park, North Carolina.

Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Study ID
NCT02583646
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
8 Years - 14 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Dec 15, 2015
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: normal weight
    Girls age 8-14 below 85% in respect to weight for their age group
  • Arm: overweight
    Girls age 8-14 at or above 85% in respect to weight for their age group

Primary Outcome Measure

To determine the correlation between Tanner breast staging and breast maturation scores using breast ultrasound in girls [ Time Frame: semiannually ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NIEHS, Research Triangle ParkResearch Triangle ParkNorth Carolina27709
NIEHS Join A Study Recruitment Group
[email protected]
855-696-4347

Find similar trials in Research Triangle Park, NC

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
NIEHS, Research Triangle Park· Research Triangle Park, NC

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