Hydrocortisone (capsule)
Drugsalivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.
NCT Number: NCT05457296
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
University hospital La Rabta, Tunis, Tunisia
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-patients with corticotrope deficiency treated with hydrocortisone for at least one year.
Exclusion criteria
salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.
Time frame: during the four hours test
very high salivary cortisol levels after the intake of hydrocortisone in tablet form as compared with capsule form.
Time frame: salivary cortisol levels during the four hours test
patients under-treated, over-treated or well treated (comparison of salivary cortisol levels with those of healthy controls)
University Tunis El Manar
Other
Saliva Cortisol Measurement for the Assessment of Hydrocortisone Replacement Therapy in Secondary Adrenal Insufficiency Patients
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