Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.
Primary Purpose
Adrenal Insufficiency
Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Hydrocortisone (capsule)
Sponsored by
About this trial
This is an interventional treatment trial for Adrenal Insufficiency focused on measuring Adrenal Insufficiency, hydrocortisone, salivary cortisol, pharmacokinetic
Eligibility Criteria
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.
Sites / Locations
- university hospital La Rabta
- University hospital La Rabta
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
capsule hydrocortisone intake in patients with corticotrope deficiency
tablet hydrocortisone intake in patients with corticotrope deficiency
healthy controls
Arm Description
Hydrocortisone taken in capsule form (15mg), one intake/ one day test.
Hydrocortisone taken in tablet form (15mg), one intake/ one day test.
healthy non treated controls, one day test.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05457296
Brief Title
Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.
Official Title
Saliva Cortisol Measurement for the Assessment of Hydrocortisone Replacement Therapy in Secondary Adrenal Insufficiency Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Insufficiency
Keywords
Adrenal Insufficiency, hydrocortisone, salivary cortisol, pharmacokinetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
prospective case control and randomized crossover clinical trial
Masking
ParticipantCare Provider
Masking Description
healthy volunteers
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
capsule hydrocortisone intake in patients with corticotrope deficiency
Arm Type
Experimental
Arm Description
Hydrocortisone taken in capsule form (15mg), one intake/ one day test.
Arm Title
tablet hydrocortisone intake in patients with corticotrope deficiency
Arm Type
Active Comparator
Arm Description
Hydrocortisone taken in tablet form (15mg), one intake/ one day test.
Arm Title
healthy controls
Arm Type
No Intervention
Arm Description
healthy non treated controls, one day test.
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone (capsule)
Intervention Description
salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.
Primary Outcome Measure Information:
Title
Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form.
Description
very high salivary cortisol levels after the intake of hydrocortisone in tablet form as compared with capsule form.
Time Frame
during the four hours test
Secondary Outcome Measure Information:
Title
Evaluation of the quality of the substitution of corticotrope deficiency with hydrocortisone using salivary cortisol measurement
Description
patients under-treated, over-treated or well treated (comparison of salivary cortisol levels with those of healthy controls)
Time Frame
salivary cortisol levels during the four hours test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meriem Kallel, professor
Organizational Affiliation
Research committee of the university hospital La Rabta
Official's Role
Study Chair
Facility Information:
Facility Name
university hospital La Rabta
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
Facility Name
University hospital La Rabta
City
Tunis
ZIP/Postal Code
1068
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
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Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.
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