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Completed

NCT Number: NCT04139447

DAnalysis of the Distribution of Adrenal Steroids in a Control Population

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.

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Key information

Conditions

Adrenal Disease Adrenal Gland Diseases Endocrine System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU, Hôpital Claude Huriez

Lille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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 outcomes

  1. Blood pressure taken while sitting, lying or standing

    Time frame: At baseline

  2. blood concentration of kaliemia

    Time frame: at baseline

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • AREM (Association Régionale Endocrinologie Métabolisme)

Registry information

Official study title

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

Acronym: STEROTEM

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2019
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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