Investigating the Impact of Obesity on Pubertal Development in Girls
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02583646|
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : August 26, 2019
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.
To find out if overweight girls go through puberty earlier than normal weight girls.
Healthy girls 8-14 years old who:
- Are normal weight or overweight
- Have some breast development
- Have not started their first period
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.
|Condition or disease|
|Obesity Puberty Normal Physiology|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Investigating the Impact of Obesity on Pubertal Development in Girls|
|Actual Study Start Date :||December 15, 2015|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Girls age 8-14 below 85% in respect to weight for their age group
Girls age 8-14 at or above 85% in respect to weight for their age group
- To determine the correlation between Tanner breast staging and breast maturation scores using breast ultrasound in girls [ Time Frame: semi annually ]To test the hypothesis that breast maturation in obese and normal weight girls primarily reflects hypothalamic-pituitary-ovarian activation as opposed to local (breast adipose tissue) estrogen production, we will use linear regression to determine if the relationship between breast maturation and ovarian size, uterine size and bone age (all markers of end organ response to estrogen) differs between the two weight groups (group by ovarian/uterine size/bone age interaction term). The finding of similar regression lines in the two groups would support this hypothesis while an upward shift in the regression line line (greater y-intercept, similar slope) in the obese girls would indicate that a given breast maturation stage is achieved at a smaller ovarian/uterine volume and younger bone age in obese girls, suggesting the presence of an additional source of estrogen (adipose tissue) in obese girls.
- To determine the contribution of peripheral aromatization to breast development in obese girls. [ Time Frame: semiannually ]Repeated measures from the same subject (visits 1,2, and follow up visits) will provide preliminary data for future studies investigating whether there is a difference in the pace of pubertal development in obese compared with normal weight girls.Squamous cells in the urine sample will be categorized as either "superficial" (mature; eg indicating estrogen exposure) or "other". The primary measure of estrogenization will be the percent of superficial cells (% S), as previously described (Adgent '13, Robine '88). The %S will be compared between normal weight and obese subjects after controlling for breast stage determined by ultrasound. We anticipate that up to 25% of urine specimens may need to be excluded because of insufficient cells or inflammation and this may require an increase in enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583646
|Contact: Imke Kirste||(984) email@example.com|
|United States, North Carolina|
|NIEHS, Research Triangle Park||Recruiting|
|Research Triangle Park, North Carolina, United States, 27709|
|Contact: Lisa Murphy 919-541-9839 firstname.lastname@example.org|
|Principal Investigator:||Natalie D Shaw, M.D.||National Institute of Environmental Health Sciences (NIEHS)|