Investigating the Impact of Obesity on Pubertal Development in Girls



Status:Recruiting
Conditions:Healthy Studies, Obesity Weight Loss
Therapuetic Areas:Endocrinology, Other
Healthy:No
Age Range:8 - 14
Updated:10/19/2018
Start Date:October 21, 2015
End Date:September 30, 2020
Contact:Imke Kirste
Email:imke.kirste@nih.gov
Phone:(984) 287-4424

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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.

Over the past decade, there has been an alarming trend toward earlier breast development in
girls. The contemporaneous obesity epidemic has led to speculation that obesity may be
driving early puberty. However, questions remain about the validity of reports of early
puberty among obese girls due to the difficulty in distinguishing fatty tissue from breast
tissue in this population. The physiological basis for early puberty among obese girls is
also unknown. The current proposal aims to investigate pubertal development in pre-menarchal
obese compared with normal weight girls using more robust methods such as breast
morphological staging via ultrasonography and intensive reproductive axis phenotyping. Study
procedures include blood draws, DXA (for body composition), hand x-ray (for bone age), breast
and transabdominal (pelvic) ultrasounds, and anthropometrics.

- 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.
We found this trial at
1
site
Research Triangle Park, North Carolina 27709
Phone: 919-541-9839
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Research Triangle Park, NC
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