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Completed

NCT Number: NCT05457296

Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University hospital La Rabta, Tunis, Tunisia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrocortisone (capsule)

Drug

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

Primary outcomes

  1. Oral contamination of salivary cortisol measurement with hydrocortisone taken in tablet form.

    Time frame: during the four hours test

    very high salivary cortisol levels after the intake of hydrocortisone in tablet form as compared with capsule form.

Secondary outcomes

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

    Time frame: salivary cortisol levels during the four hours test

    patients under-treated, over-treated or well treated (comparison of salivary cortisol levels with those of healthy controls)

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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