DAnalysis of the Distribution of Adrenal Steroids in a Control Population

Analysis of the Distribution of Adrenal Steroids in Blood and Urine Measured by Mass Spectrometry Coupled to Liquid Chromatography in a Control Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04139447

Acronym

STEROTEM

Enrollment

Registered

2019-10-25

Start date

2015-02-28

Completion date

2018-09-30

Last updated

2019-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Disease

Keywords

Adrenal steroids, mass spectroscopy, liquid chromatography

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results