Clinical Trials Logo
  1. Home
  2. Adrenal Insufficiency
  3. NCT05457296

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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05457296
Study type Interventional
Source University Tunis El Manar
Contact
Status Completed
Phase Phase 4
Start date January 1, 2021
Completion date April 30, 2021
View Details
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03282487 - Optimising Steroid Replacement in Patients With Adrenal Insufficiency Phase 4
Not yet recruiting NCT05716607 - Treatment Study in Patients Treated With Both Insulin & Hydrocortisone N/A
Recruiting NCT03399383 - Adherence in Chronic Adrenal Insufficiency N/A
Completed NCT01428336 - Value of 25 mcg Cortrosyn Stimulation Test N/A
Completed NCT00851942 - Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test Phase 4
Withdrawn NCT00368381 - Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis Phase 4
Active, not recruiting NCT04519580 - Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Recruiting NCT06008184 - Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids
Completed NCT03013166 - THIN Database Study: Resource Use and Outcomes in Patients With Adrenal Insufficiency Prescribed Hydrocortisone: Immediate, or Modified Release, or Prednisolone
Enrolling by invitation NCT02282150 - Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism Phase 4
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Completed NCT03000231 - Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency
Completed NCT01960530 - An Investigational Study of Hydrocortisone Phase 1
Completed NCT00552487 - Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis N/A
Completed NCT00575341 - Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency Phase 3
Completed NCT00471900 - Six Months DHEA Treatment in Female Adrenal Failure N/A
Recruiting NCT03294876 - Rheumatoid Arthritis Adrenal Recovery Study
Completed NCT03709381 - Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Children Study Early Phase 1
Recruiting NCT05639127 - The Treatment of Adrenal Crisis With Inhaled Prednisolone Early Phase 1
Completed NCT04488432 - Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant