DAnalysis of the Distribution of Adrenal Steroids in a Control Population

NCT ID: NCT04139447

Last Updated: 2019-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-09-30

Brief Summary

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This is a biomedical research study on the determination of adrenal steroids. It has been proposed in recent years as a tool for the diagnostic orientation of an adrenal pathology. The main objective is to analyze the distribution of blood and urinary adrenal steroid values in a population of 60 controls. The secondary objective is to establish reference values for each of these parameters, if their distribution permits, and to study the possible link between the blood pressure level, the orthostatism state, the potassium level and these adrenal steroids.

Detailed Description

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Conditions

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Adrenal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Negative blood pregnancy test
* Normosalt diet
* Men and women ≥ 18 years
* Being able and willing to give written informed consent

Exclusion Criteria

* Personal history of diabetes, high blood pressure, adrenal pathologies.
* Family history of adrenal pathologies.
* Taking of the following drugs:

Antihypertensives drugs: ACE inhibitor, Angiotensin II receptor, beta-blocker, thiazide diuretic, loop diuretic, anti-aldosterone, dihydropyridine-type calcium antagonist.

* Hormone replacement therapy, cyproterone acetate
* NSAID (except occasional intake), corticosteroid
* Antidepressant: serotonin reuptake inhibitor (paroxetine, fluoxetine, sertraline, citalopram)
* Contraception or estrogen / progestin treatment (progestins only allowed)
* Not be able to keep standing position.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AREM (Association Régionale Endocrinologie Métabolisme)

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Douillard, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHRU, Hôpital Claude Huriez

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2013-A01632-43

Identifier Type: OTHER

Identifier Source: secondary_id

2013_11

Identifier Type: -

Identifier Source: org_study_id

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