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NCT02052479 · ClinicalTrials.gov registry record · NA

Insulin Differences Between African-American and Caucasian Female Adolescents With Polycystic Ovary Syndrome (PCOS)

A NA study, sponsored by Nationwide Children's Hospital.

Terminated
Registry status
NA
Development phase
12
Enrollment target

NCT02052479: Clinical Trial NA study, sponsored by Nationwide Children's Hospital.

NCT02052479 is a NA study that was terminated before completion, run by Nationwide Children's Hospital. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02052479, a NA study, was terminated before completion, sponsored by Nationwide Children's Hospital.

TERMINATED
Registry status
NA
Development phase
12 participants
Enrollment target

Study Summary

The purpose of this research study is to see if there are differences between African-American and Caucasian girls with Polycystic Ovary Syndrome (PCOS) in how their bodies respond to a type of sugar, called glucose, the body's main source of energy. PCOS is one of the most common endocrine disorders among females. Features can include anovulation (eggs are not released from the ovaries) resulting in irregular menstrual periods, excessive amounts of androgenic (male) hormones resulting in acne and hirsutism (excessive hair growth on the face and body), and polycystic ovaries (small sac-like structures \[cysts\] on your ovaries) seen on ultrasound. Girls with PCOS also have higher levels of insulin in their bodies (called hyperinsulinism) but are not able to use insulin very well (called insulin resistance) resulting in an increased risk of diabetes. Diabetes is when you have high levels of glucose (sugar) in your blood. Many studies have looked at how bodies respond to glucose and have shown that compared to Caucasians, healthy African-Americans produce much more insulin (hyperinsulinism) but are not able to use it as well (insulin resistance) in childhood, adolescence, and adulthood. Insulin is a hormone that helps glucose move from the blood into the muscles for the body to use as energy. PCOS is associated with increased levels of insulin (hyperinsulinism) and not being able to use it as well (insulin resistance). So we want to see if there is a difference in insulin production (secretion) and insulin resistance between African-Americans and Caucasians girls with PCOS. To do this, we will look at blood glucose and insulin levels in response to giving glucose in African-American and Caucasian girls who have PCOS. The results of this study may ultimately help to more effectively target treatment therapy in individuals with PCOS that have increased insulin secretion and/or increased insulin resistance.

Primary Outcome

The objective of this study is to examine the differences in insulin secretion between AA and CA adolescents with PCOS. Primary Aim: To determine the influence of racial/ethnic background on insulin secretion in adolescent females with PCOS.

Interventions

  • OTHER Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2014-01
Est. Completion 2015-06
Phase NA
Nationwide Children's Hospital

188 total trials

Why NCT02052479 stopped before completion

NCT02052479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT) is the first listed.

NCT02052479 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02052479 about?

NCT02052479 is a clinical study titled "Insulin Differences Between African-American and Caucasian Female Adolescents With Polycystic Ovary Syndrome (PCOS)". The purpose of this research study is to see if there are differences between African-American and Caucasian girls with Polycystic Ovary Syndrome (PCOS) in how their bodies respond to a type of sugar, called glucose, the body's main source of energy. PCOS is one of the most common endocrine disorder...

What is the current status of trial NCT02052479?

This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2014-01. Estimated completion is 2015-06.

What interventions are being tested in trial NCT02052479?

The interventions under investigation include: Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT) (OTHER).

Who is sponsoring clinical trial NCT02052479?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02052479's enrollment target sits among peer trials

12 1913th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02052479, the US trial registry maintained by the National Library of Medicine. NCT02052479 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.