Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-04-30

Brief Summary

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Patients with adrenal insufficiency are most often overdosed with hydrocortisone. To date, there is no reliable marker that can reflect the quality of hydrocortisone substitution. Salivary cortisol is a good reflection of free plasmatic cortisol. However, salivary contamination with the oral intake of hydrocortisone has been described.

The aims of the study are to:

* evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form and determine its risk factors.
* evaluate the quality of hydrocortisone substitution in patients with corticotrope deficiency.

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Detailed Description

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Patients with adrenal insufficiency are most often overdosed with hydrocortisone, as evidenced by the higher frequency of metabolic disorders, osteoporosis and cardiovascular mortality in these subjects compared to healthy subjects. To date, there is no reliable marker that can reflect the quality of hydrocortisone substitution. Salivary cortisol is a good reflection of free plasmatic cortisol. However, salivary contamination with the oral intake of hydrocortisone has been described.

The aims of the study are to:

* evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form and determine its risk factors.
* evaluate the quality of hydrocortisone substitution in patients with corticotrope deficiency.

It is a cross over clinical trial with three arms: patients taking tablets of hydrocortisone, patients taking capsules of hydrocortisone, and healthy control subjects undergoing one day test. Salivary cortisol is measured before, at one, two and four hours after hydrocortisone intake.

Conditions

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Adrenal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

prospective case control and randomized crossover clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

healthy volunteers

Study Groups

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capsule hydrocortisone intake in patients with corticotrope deficiency

Hydrocortisone taken in capsule form (15mg), one intake/ one day test.

Group Type EXPERIMENTAL

Hydrocortisone (capsule)

Intervention Type DRUG

salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.

tablet hydrocortisone intake in patients with corticotrope deficiency

Hydrocortisone taken in tablet form (15mg), one intake/ one day test.

Group Type ACTIVE_COMPARATOR

Hydrocortisone (capsule)

Intervention Type DRUG

salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.

healthy controls

healthy non treated controls, one day test.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hydrocortisone (capsule)

salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-patients with corticotrope deficiency treated with hydrocortisone for at least one year.

Exclusion Criteria

* alcoholism,
* morbid obesity,
* long standing or uncontrolled diabetes mellitus,
* uncontrolled hypothyroidism,
* depression,
* chronic or acute inflammatory or infectious disease,
* neoplasia,
* renal or hepatic disease,
* malabsorption,
* pregnant or breast-feeding women,
* treatment with corticosteroids other than hydrocortisone, enzyme inducers or oestrogens.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes