Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

University Tunis El Manar40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form.

very high salivary cortisol levels after the intake of hydrocortisone in tablet form as compared with capsule form.

Time frame: during the four hours test

Secondary Outcomes

Evaluation of the quality of the substitution of corticotrope deficiency with hydrocortisone using salivary cortisol measurement

patients under-treated, over-treated or well treated (comparison of salivary cortisol levels with those of healthy controls)

Time frame: salivary cortisol levels during the four hours test