Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

Phase 4

Completed

• Conditions: Adrenal Insufficiency
• Interventions: Drug: Hydrocortisone (capsule)

• Registration Number: NCT05457296
• Lead Sponsor: University Tunis El Manar

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-03-03
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-11
• Last Update Submitted: 2022-07-11
• Study First Posted: 2022-07-13
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
capsule hydrocortisone intake in patients with corticotrope deficiency	Hydrocortisone (capsule)	Hydrocortisone taken in capsule form (15mg), one intake/ one day test.
tablet hydrocortisone intake in patients with corticotrope deficiency	Hydrocortisone (capsule)	Hydrocortisone taken in tablet form (15mg), one intake/ one day test.

Primary Outcome Measures

Name	Time	Method
Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form.	during the four hours test	very high salivary cortisol levels after the intake of hydrocortisone in tablet form as compared with capsule form.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the quality of the substitution of corticotrope deficiency with hydrocortisone using salivary cortisol measurement	salivary cortisol levels during the four hours test	patients under-treated, over-treated or well treated (comparison of salivary cortisol levels with those of healthy controls)

Trial Locations

Locations (2)

university hospital La Rabta; 🇹🇳 Tunis, Tunisia

University hospital La Rabta; 🇹🇳 Tunis, Tunisia