DAnalysis of the Distribution of Adrenal Steroids in a Control Population

Adrenal Disease Clinical Trial

— STEROTEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139447
• Other study ID #: 2013_11
• Secondary ID: 2013-A01632-43
• Status: Completed
• Start date: February 2015
• Est. completion date: September 2018

Study information

• Verified date: October 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Disease
• Adrenal Gland Diseases

Locations

Country	Name	City	State
France	CHRU, Hôpital Claude Huriez	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	AREM (Association Régionale Endocrinologie Métabolisme)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Blood pressure taken while sitting, lying or standing		At baseline
Secondary	blood concentration of kaliemia		at baseline