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NCT01143493 · ClinicalTrials.gov registry record

The Role of Glucocorticoid Receptor SNPs in Receptor Function and Metabolic Disease

A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).

Completed
Registry status
278
Enrollment target

NCT01143493: Completed study, sponsored by National Institute of Environmental Health Sciences (NIEHS).

NCT01143493 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 278 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01143493 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).

COMPLETED
Registry status
278 participants
Enrollment target

Study Summary

Background: \- Glucocorticoids are primary stress response hormones released from the adrenal gland when an individual is under stress. Chronic or ongoing elevation of these hormones due to prolonged stress or medical treatments can have numerous harmful effects. Researchers are interested in learning more about how these hormones affect cell growth, development, and death. To study glucocorticoid hormones, researchers plan to use the medication dexamethasone, which affects the parts of cells that respond to glucocorticoid hormones. Objectives: \- To study glucocorticoid stress hormones in healthy individuals before and after receiving dexamethasone. Eligibility: * Healthy individuals at least 18 years of age. * Participants must not be using certain medications that may affect the dexamethasone test, including hormonal contraception, steroid-based drugs, and some antidepressants. Design: * This study will require an initial screening visit and a second study visit. The visits are estimated to require about 1 to 2 hours of participation over a period of up to 14 days. * Participants will be screened at visit 1 with a full physical examination and medical history, and an initial blood sample for testing. * For visit 2, participants will be asked to abstain from all food and drinks except for water for 12 hours before the appointment, and will take one tablet of dexamethasone 9 hours before the appointment. * Participants will have a second blood sample taken during visit 2, and will receive a snack after the blood is drawn.

Primary Outcome

The null hypothesis for this endpoint (primary hypothesis for this study) is that there is no difference among genotypes in the change from baseline cortisol level. The two-sided alternative hypothesis is that there is a trend(homozygous wild-type to heterozygous to homozygous for the minor allele) in change from baseline.

Trial Details

FieldValue
Enrollment Target 278 participants
Start Date 2010-09-30
Est. Completion 2019-12-02

What the finished NCT01143493 record still lists

NCT01143493 is an observational study that tracks outcomes without assigning an intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01143493 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01143493 about?

NCT01143493 is a clinical study titled "The Role of Glucocorticoid Receptor SNPs in Receptor Function and Metabolic Disease". Background: \- Glucocorticoids are primary stress response hormones released from the adrenal gland when an individual is under stress. Chronic or ongoing elevation of these hormones due to prolonged stress or medical treatments can have numerous harmful effects. Researchers are interested in learn...

What is the current status of trial NCT01143493?

This trial is currently completed. The enrollment target is 278 participants. The study started on 2010-09-30. Estimated completion is 2019-12-02.

Who is sponsoring clinical trial NCT01143493?

This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01143493, the US trial registry maintained by the National Library of Medicine. NCT01143493 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.