Clinical Trials Logo
  1. Home
  2. Adrenal Insufficiency
  3. NCT06260462

Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency

Adrenal Insufficiency Clinical Trial

Official title:
Conventional Glucocorticoids vs. Dual-release Hydrocortisone Effects on Metabolic, Cardiovascular, and Bone Outcomes in Treatment-naïve Patients With Adrenal Insufficiency: a 10-year Prospective Randomised Study

Clinical Trial Summary

The current study is a randomized, open study aimed to compare the effects of conventional glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric, metabolic, cardiovascular and bone outcomes in treatment-naïve patients with primary adrenal insufficiency and secondary adrenal insufficiency in a 10 year-observation period.

Clinical Trial Description

Adrenal insufficiency (AI) can be caused by a disease involving the adrenal gland resulting in inadequate secretion of adrenal cortex hormones, primary adrenal insufficiency (PAI). Secondary adrenal insufficiency (SAI) results from a decreased level of adrenocorticotrophin hormone (ACTH) released from the pituitary gland. The mainstay of treatment of PAI and SAI is glucocorticoid (GC) replacement therapy. Conventional steroid replacement therapy includes cortisone acetate and hydrocortisone administered 2-3 times a day with the highest dose in the morning and the lowest dose in the afternoon. These dosing regimens have been designed to mimic the peak of cortisol secretion in the morning and avoid overdosing during the night hours, even though a higher risk of developing comorbidities has been shown, notably in patients treated with higher evening doses. In patients with AI on conventional steroid replacement therapy, mortality remains higher than in the general population, mainly due to non-physiological daily GC overexposure and to inadequate cortisol exposure during stress-related events and illness. Studies aiming to evaluate the long-term clinical outcomes of patients with AI on conventional steroid replacement therapy clearly showed increased comorbidities, mainly related to the dose used. By contrast, dual-release hydrocortisone (DR-HC) is characterized by once-daily administration with high release of hydrocortisone immediately after intake and a very low release in the evening and nocturnal hours. The switch from conventional GC therapy to DR-HC has been shown to be associated with improvement in BMI, hepatic, bone and glucometabolic parameters and QoL. However, long-term clinical outcomes of patients treated with DR-HC in patients naïve to steroid treatment are not known. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06260462
Study type Interventional
Source University of Palermo
Contact
Status Completed
Phase Phase 3
Start date January 1, 2012
Completion date December 30, 2023
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
Not yet recruiting NCT06435481 - Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics Phase 4
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
Completed 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