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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 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.

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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.

Study Locations (1)

North Carolina

  • NIEHS, Research Triangle Park - Research Triangle Park

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2015-12-15
Est. Completion 2026-09-30

What the Registry Record Tells You About NCT02583646

The ClinicalTrials.gov registry entry for NCT02583646 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 0 interventions.

NCT02583646 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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