Adrenal Insufficiency
Conditions
Keywords
Adrenal Insufficiency, hydrocortisone, salivary cortisol, pharmacokinetic
Brief 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.
Detailed 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.
Interventions
DRUGHydrocortisone (capsule)
salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
healthy volunteers
Intervention model description
prospective case control and randomized crossover clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form. | during the four hours test | very high salivary cortisol levels after the intake of hydrocortisone in tablet form as compared with capsule form. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the quality of the substitution of corticotrope deficiency with hydrocortisone using salivary cortisol measurement | 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) |
Countries
Tunisia
Outcome results
None listed