Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

Phase

Condition

Hormone Deficiencies

Cushing's Disease

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT05457296

101

Ages 18-65
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

-patients with corticotrope deficiency treated with hydrocortisone for at least one year.

Exclusion

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 oroestrogens.

Study Design

January 01, 2021

April 30, 2021

Study 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.