DAnalysis of the Distribution of Adrenal Steroids in a Control Population (STEROTEM)

October 24, 2019 updated by: University Hospital, Lille

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • CHRU, Hôpital Claude HURIEZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline
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)
At baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

AREM (Association Régionale Endocrinologie Métabolisme)

Investigators

  • Principal Investigator: Claire Douillard, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013_11
  • 2013-A01632-43 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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