Investigating the Impact of Obesity on Pubertal Development in Girls

NCT02583646 | Recruiting

• 2 other identifiers: 16000616-E-0006
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Puberty; Normal Physiology

Keywords

Obesity; Puberty; Ultrasound; Pediatric; Natural History

Outcome Measures

Primary Outcomes (1)

• To determine the correlation between Tanner breast staging and breast maturation scores using breast ultrasound in girls

  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 (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.

  semiannually

Secondary Outcomes (1)

• To determine the contribution of peripheral aromatization to breast development in obese girls.

  semiannually

Study Arms (2)

normal weight

Girls age 8-14 below 85% in respect to weight for their age group

overweight

Girls age 8-14 at or above 85% in respect to weight for their age group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

community sample

You may qualify if:

• Girls without a chronic medical condition
• Normal weight (BMI 5th-85th%) or overweight/obese (BMI \> 85th%)
• years old
• Some breast development
• Pre-menarchal

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

Related Publications (4)

• 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. doi: 10.1542/peds.113.4.911. No abstract available.

  PMID: 15060243 BACKGROUND

• 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.

  PMID: 18245513 BACKGROUND

• 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.

  PMID: 19541497 BACKGROUND

• Ortega MT, McGrath JA, Carlson L, Flores Poccia V, Larson G, Douglas C, Sun BZ, Zhao S, Beery B, Vesper HW, Duke L, Botelho JC, Filie AC, Shaw ND. Longitudinal Investigation of Pubertal Milestones and Hormones as a Function of Body Fat in Girls. J Clin Endocrinol Metab. 2021 May 13;106(6):1668-1683. doi: 10.1210/clinem/dgab092.

  PMID: 33630047 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Natalie D Shaw, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIEHS Join A Study Recruitment Group

CONTACT

(855) 696-4347; myniehs@nih.gov

Natalie D Shaw, M.D.

CONTACT

(984) 287-3716; natalie.shaw@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 22, 2015
• Study Start: December 15, 2015
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 8, 2026

Record last verified: 2025-12-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)