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Trial record 13 of 701 for:    eating disorders OR anorexia OR appetite disorder OR binge eating disorder OR bulimia OR coprophagia OR hyperphagia OR pica disease OR purge OR orthorexia OR feeding behaviors OR nutrition disorders OR obesity OR thinness OR women's health | Recruiting, Not yet recruiting, Available Studies | NIH

Investigating the Impact of Obesity on Pubertal Development in Girls

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ClinicalTrials.gov Identifier: NCT02583646
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

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.


Condition or disease
Obesity Puberty Normal Physiology

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Puberty

Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
community sample
Criteria
  • 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.


Information from the National Library of Medicine

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


Contacts
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Contact: Imke Kirste (984) 287-4424 imke.kirste@nih.gov

Locations
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United States, North Carolina
NIEHS, Research Triangle Park Recruiting
Research Triangle Park, North Carolina, United States, 27709
Contact: Lisa Murphy    919-541-9839    murphylb@mail.nih.gov   
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Natalie D Shaw, M.D. National Institute of Environmental Health Sciences (NIEHS)

Additional Information:
Publications:
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Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT02583646     History of Changes
Other Study ID Numbers: 160006
16-E-0006
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 20, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ):
Obesity
Puberty
Ultrasound
Pediatric
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms