Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

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

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.

Study Overview

• Status: Completed
• Conditions: Adrenal Insufficiency
• Intervention / Treatment: Drug: Hydrocortisone (capsule)

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1007
    • University Hospital La Rabta
  • Tunis, Tunisia, 1068
    • University Hospital La Rabta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Study Chair: Meriem Kallel, professor, Research committee of the university hospital La Rabta

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: pharmacokinetic; hydrocortisone; salivary cortisol; Adrenal Insufficiency
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenal Insufficiency; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: 101 (Other Identifier: Hamilton Integrated Research Ethics Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No