DAnalysis of the Distribution of Adrenal Steroids in a Co... | NCT04139447

Studies
DAnalysis of the Distribution of Adrenal Steroids in a Control Population

NCT04139447

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Oct 25, 2019Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Adrenal Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-A01632-43	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Sep 2018Actual

Completion Date

Sep 2018Actual

First Submitted Date

Jan 14, 2019

First Submission Date that Met QC Criteria

Oct 24, 2019

First Posted Date

Oct 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2019

Last Update Posted Date

Oct 25, 2019Actual

Name	Class
AREM (Association Régionale Endocrinologie Métabolisme)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Label	Type	Description	Intervention Names
Healthy subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claire Douillard, MD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU, Hôpital Claude Huriez		Lille			France

ID	Term
D000307	Adrenal Gland Diseases

ID	Term
D004700	Endocrine System Diseases

Description

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)