Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

Adrenal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05457296
• Other study ID #: 101
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2022
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

Drug:
• Hydrocortisone (capsule)
salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.

Locations

Country	Name	City	State
Tunisia	university hospital La Rabta	Tunis
Tunisia	University hospital La Rabta	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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