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Saliva Cortisol Measurement for the Assessment of Hydrocortisone Replacement Therapy in Secondary Adrenal Insufficiency Patients
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
university hospital La Rabta
Tunis, Tunisia
University hospital La Rabta
Tunis, Tunisia
Start Date
January 1, 2021
Primary Completion Date
April 30, 2021
Completion Date
April 30, 2021
Last Updated
July 13, 2022
40
ACTUAL participants
Hydrocortisone (capsule)
DRUG
Lead Sponsor
University Tunis El Manar
NCT02769975
NCT01661387
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