DAnalysis of the Distribution of Adrenal Steroids in a Control Population

NCT04139447 | Completed DMC

• 2 other identifiers: 2013_112013-A01632-43
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Disease

Keywords

Adrenal steroids; mass spectroscopy; liquid chromatography

Outcome Measures

Primary Outcomes (2)

• difference of the distribution of blood steroid values in a population control group

  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

  At baseline

• difference of the distribution of urinary steroid values in a population control group

  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)

  At baseline

Secondary Outcomes (2)

• Blood pressure taken while sitting, lying or standing

  At baseline

• blood concentration of kaliemia

  at baseline

Study Arms (1)

Healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Biomedical research to analyze the distribution of blood and urinary adrenal steroid values in a population of 60 healthy controls.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• AREM (Association Régionale Endocrinologie Métabolisme): collaborator

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, urine. * blood ionogram, serum creatinine, CO2T (heparin tube) * Plasma Renin Activity 5PRA) * Steroid blood (B, 18-OH B, DOC, 18-OH DOC, S, F, 18-OH F, 17-OH progesterone, 21-deoxycortisol, delta 4 androstenedione, 17-OH pregnenolone, aldosterone, SDHA) * Urine ionogram (natriuresis, kaliuresis) * Steroid Urine (E, F, THF, aTHF, THE, aldosterone)

MeSH Terms

Conditions

Adrenal Gland Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Claire Douillard, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: October 25, 2019
• Study Start: February 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

FR (1)