Investigating the Impact of Obesity on Pubertal Development in Girls

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age8-14
SponsorNational Institute of Environmental Health Sciences (NIEHS)

About this trial

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.

Eligibility criteria

Qualifiers

Girls without a chronic medical condition

Normal weight (BMI 5th-85th%) or overweight/obese (BMI > 85th%)

8-14 years old

Some breast development

Disqualifiers

Treated with medications that may affect reproductive hormones (e.g. birth control pills).

Pregnancy

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

150 Participants
are grouped into 2 trial groups