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NCT02583646 · ClinicalTrials.gov registry record
Investigating the Impact of Obesity on Pubertal Development in Girls
A clinical trial of Obesity and Normal Physiology, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Recruiting
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT02583646: Recruiting study of Obesity and Normal Physiology, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT02583646 is a study of Obesity and Normal Physiology that is actively recruiting participants, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 150 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02583646, a study of Obesity and Normal Physiology, is actively recruiting participants, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- RECRUITING
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 si
Conditions Studied
Study Locations (1)
North Carolina
- NIEHS, Research Triangle Park - Research Triangle Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2015-12-15 |
| Est. Completion | 2026-09-30 |
What NCT02583646 shows while recruiting
NCT02583646 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 0 interventions.
NCT02583646 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02583646 about?
NCT02583646 is a clinical study titled "Investigating the Impact of Obesity on Pubertal Development in Girls". 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 ...
What is the current status of trial NCT02583646?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2015-12-15. Estimated completion is 2026-09-30.
What conditions does trial NCT02583646 study?
This clinical trial studies the following conditions: Obesity, Normal Physiology, Puberty.
Who is sponsoring clinical trial NCT02583646?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02583646 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02583646's enrollment target sits among peer trials
150 370th of 1053 higher than 668 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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