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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
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenal Insufficiency focused on measuring Adrenal Insufficiency, hydrocortisone, salivary cortisol, pharmacokinetic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
March 3, 2021
Last Updated
July 11, 2022
Sponsor
University Tunis El Manar
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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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