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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| capsule hydrocortisone intake in patients with corticotrope deficiency | Experimental | Hydrocortisone taken in capsule form (15mg), one intake/ one day test. |
|
| tablet hydrocortisone intake in patients with corticotrope deficiency | Active Comparator | Hydrocortisone taken in tablet form (15mg), one intake/ one day test. |
|
| healthy controls | No Intervention | healthy non treated controls, one day test. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone (capsule) | Drug | salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
-patients with corticotrope deficiency treated with hydrocortisone for at least one year.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meriem Kallel, professor | Research committee of the university hospital La Rabta | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| university hospital La Rabta | Tunis | 1007 | Tunisia | |||
| University hospital La Rabta |
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| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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prospective case control and randomized crossover clinical trial
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healthy volunteers
| Tunis |
| 1068 |
| Tunisia |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |