Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

Study Overview
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Brief Summary
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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: 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
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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.

Official Title
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Saliva Cortisol Measurement for the Assessment of Hydrocortisone Replacement Therapy in Secondary Adrenal Insufficiency Patients

Conditions
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Adrenal Insufficiency

Intervention / Treatment
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* Drug: Hydrocortisone (capsule)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: prospective case control and randomized crossover clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: capsule hydrocortisone intake in patients with corticotrope deficiency<br>Hydrocortisone taken in capsule form (15mg), one intake/ one day test. | Drug: Hydrocortisone (capsule)<br>* salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.<br>|
| Active Comparator: tablet hydrocortisone intake in patients with corticotrope deficiency<br>Hydrocortisone taken in tablet form (15mg), one intake/ one day test. | Drug: Hydrocortisone (capsule)<br>* salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.<br>|
| No Intervention: healthy controls<br>healthy non treated controls, one day test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adrenal Insufficiency, hydrocortisone, salivary cortisol, pharmacokinetic