Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

NCT05457296 | Completed Phase 4

• 1 other identifier: 101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Adrenal Insufficiency

Keywords

Adrenal Insufficiency; hydrocortisone; salivary cortisol; pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of the quality of the substitution of corticotrope deficiency with hydrocortisone using salivary cortisol measurement

  salivary cortisol levels during the four hours test

Study Arms (3)

capsule hydrocortisone intake in patients with corticotrope deficiency

EXPERIMENTAL

Hydrocortisone taken in capsule form (15mg), one intake/ one day test.

Drug: Hydrocortisone (capsule)

tablet hydrocortisone intake in patients with corticotrope deficiency

ACTIVE COMPARATOR

Hydrocortisone taken in tablet form (15mg), one intake/ one day test.

Drug: Hydrocortisone (capsule)

healthy controls

NO INTERVENTION

healthy non treated controls, one day test.

Interventions

Hydrocortisone (capsule) DRUG

salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.

capsule hydrocortisone intake in patients with corticotrope deficiency; tablet hydrocortisone intake in patients with corticotrope deficiency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with corticotrope deficiency treated with hydrocortisone for at least one year.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (2)

university hospital La Rabta

Tunis, 1007, Tunisia

Location

University hospital La Rabta

Tunis, 1068, Tunisia

Location

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Hydrocortisone; Capsules

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Meriem Kallel, professor

  Research committee of the university hospital La Rabta

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: healthy volunteers
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: prospective case control and randomized crossover clinical trial

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: July 13, 2022
• Study Start: January 1, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)