Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

Sponsor

University Tunis El Manar (Other)

Overall Status

Completed

CT.gov ID

NCT05457296

Collaborator

(none)

Enrollment

Locations

Arms

3.9

Actual Duration (Months)

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adrenal Insufficiency	Drug: Hydrocortisone (capsule)	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

prospective case control and randomized crossover clinical trialprospective case control and randomized crossover clinical trial

Masking:

Double (Participant, Care Provider)

Masking Description:

healthy volunteers

Primary Purpose:

Treatment

Official Title:

Saliva Cortisol Measurement for the Assessment of Hydrocortisone Replacement Therapy in Secondary Adrenal Insufficiency Patients

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: capsule hydrocortisone intake in patients with corticotrope deficiency Hydrocortisone taken in capsule form (15mg), one intake/ one day test.	Drug: Hydrocortisone (capsule) salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.
Active Comparator: tablet hydrocortisone intake in patients with corticotrope deficiency Hydrocortisone taken in tablet form (15mg), one intake/ one day test.	Drug: Hydrocortisone (capsule) salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.
No Intervention: healthy controls healthy non treated controls, one day test.

Arm

Intervention/Treatment

Experimental: capsule hydrocortisone intake in patients with corticotrope deficiency

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

Drug: Hydrocortisone (capsule)

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

Active Comparator: tablet hydrocortisone intake in patients with corticotrope deficiency

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

Drug: Hydrocortisone (capsule)

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

No Intervention: healthy controls

healthy non treated controls, one day test.

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.