Clinical trial NCT05457296: Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.
Official title: Saliva Cortisol Measurement for the Assessment of Hydrocortisone Replacement Therapy in Secondary Adrenal Insufficiency Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adrenal Insufficiency
Keywords: Adrenal Insufficiency
hydrocortisone
salivary cortisol
pharmacokinetic
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective case control and randomized crossover clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form.
timeFrame: during the four hours test
Secondary outcomes:
measure: Evaluation of the quality of the substitution of corticotrope deficiency with hydrocortisone using salivary cortisol measurement
timeFrame: salivary cortisol levels during the four hours test
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: university hospital La Rabta
city: Tunis
country: Tunisia
facility: University hospital La Rabta
Study officials:
affiliation: Research committee of the university hospital La Rabta
name: Meriem Kallel, professor
role: STUDY_CHAIR
References: