Adrenal Insufficiency Clinical Trial
Official title:
Saliva Cortisol Measurement for the Assessment of Hydrocortisone Replacement Therapy in Secondary Adrenal Insufficiency Patients
NCT number | NCT05457296 |
Other study ID # | 101 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 1, 2021 |
Est. completion date | April 30, 2021 |
Verified date | July 2022 |
Source | University Tunis El Manar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Tunisia | university hospital La Rabta | Tunis | |
Tunisia | University hospital La Rabta | Tunis |
Lead Sponsor | Collaborator |
---|---|
University Tunis El Manar |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | during the four hours test | |
Secondary | 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) | salivary cortisol levels during the four hours test |
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