Protocol Details
Investigating the Impact of Obesity on Pubertal Development in Girls
This study is currently recruiting participants.
Summary
Number |
16-E-0006 |
Sponsoring Institute |
National Institute of Environmental Health Sciences (NIEHS) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Female
Min Age: 8 Years
Max Age: 14 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Male |
Keywords |
Obesity;
Puberty;
Ultrasound;
Pediatric;
Natural History |
Recruitment Keyword(s) |
None |
Condition(s) |
Obesity;
Puberty;
Normal Physiology |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Environmental Health Sciences |
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
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.
Citations:
Herman-Giddens ME, Kaplowitz PB, Wasserman R. Navigating the recent articles on girls' puberty in Pediatrics: what do we know and where do we go from here? Pediatrics. 2004 Apr;113(4):911-7.
Kaplowitz PB. Link between body fat and the timing of puberty. Pediatrics. 2008 Feb;121 Suppl 3:S208-17. doi: 10.1542/peds.2007-1813F.
Ahmed ML, Ong KK, Dunger DB. Childhood obesity and the timing of puberty. Trends Endocrinol Metab. 2009 Jul;20(5):237-42. doi: 10.1016/j.tem.2009.02.004. Epub 2009 Jun 21.
Contacts:
Clinical Trials Number:
NCT02583646