Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

University Tunis El Manar

Status and phase: Completed; Phase 4

Conditions: Adrenal Insufficiency

Treatments: Drug: Hydrocortisone (capsule)

Study type: Interventional

Funder types: Other

Identifiers

NCT05457296

101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 3 patient groups

capsule hydrocortisone intake in patients with corticotrope deficiency

Experimental group

Description:

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

Treatment:

Drug: Hydrocortisone (capsule)

tablet hydrocortisone intake in patients with corticotrope deficiency

Active Comparator group

Description:

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

Treatment:

Drug: Hydrocortisone (capsule)

healthy controls

No Intervention group

Description:

healthy non treated controls, one day test.