DAnalysis of the Distribution of Adrenal Steroids in a Control Population

Completed

• Conditions: Adrenal Disease

• Registration Number: NCT04139447
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Study First Submitted: 2019-01-14
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-24
• Last Update Submitted: 2019-10-24
• Study First Posted: 2019-10-25
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference of the distribution of blood steroid values in a population control group	At baseline	The value will be measured by mass spectrometry coupled with liquid chromatography (HPLC-MS) and 16 global parameters will be analyses (B, 18-OH B, DOC, 18-OH DOC, S, F, 18-OH F, 17-OH progesterone, 21-desoxycortisol, delta 4 androstenedione, 17OHpregnenolone, aldosterone, SDHA, E, testosterone, estradiol
difference of the distribution of urinary steroid values in a population control group	At baseline	The value will be measured by mass spectrometry coupled with liquid chromatography (HPLC-MS) and 6 global parameters will be analyses (E, F, THF, aTHF, THE, aldosterone)

Secondary Outcome Measures

Name	Time	Method
Blood pressure taken while sitting, lying or standing	At baseline
blood concentration of kaliemia	at baseline

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France