Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)

Condition(s) targeted: Primary Adrenal Insufficiency; Secondary Adrenal Insufficiency

Intervention: Plenadren (Drug); Conventional glucocorticoid therapy (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Roma La Sapienza

Official(s) and/or principal investigator(s):
Andrea M Isidori, MD, PhD, Principal Investigator, Affiliation: Dept. Experimental Medicine

Overall contact:
Andrea M Isidori, MD, PhD, Phone: +3906499700540, Email: andrea.isidori@uniroma1.it

This is a randomized, controlled, open, three-armed, multi-centre study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile, cardiovascular system, bone mass and quality of life in patients affected by primary or secondary adrenal insufficiency.

Official title: A Randomized, Controlled, Multi-Centre Trial on the Effects of Dual-release Hydrocortisone Preparations Versus Conventional Glucocorticoid Replacement Therapy in Patients Affected by Primary and Secondary Adrenal Insufficiency. DREAM Trial.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from baseline in measurement of weight at 3 and 6 months

Secondary outcome:

Change from baseline in metabolic status at 3 and 6 months

Evaluation of immunological profile at baseline 3 and 6 months.

Evaluation of bone deposition and resorption markers from baseline at 6 months

Evaluation of epicardial fat thickness from baseline at 6 months

Evaluation of hepatic steatosis from baseline at 6 months

Changes in quality of life from baseline at 2, 3 and 6 months

Bone mineral density

Detailed description: Hypocortisolism is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data suggest that outcome is still compromised. Patient receiving conventional glucocorticoids therapy have compromised quality of life, reduced bone mass, increased risk factors for cardiovascular disease, infectious, tumors and premature mortality that is more than twice the mortality rate in the background population. Circulating cortisol levels follow a distinct diurnal pattern with high levels in the early morning and low trough values around midnight. Using available formulations for replacement therapy this circadian rhythm is had to mimic and also during the active time of the day high peaks and low troughs occur. In this trial a dual-release hydrocortisone preparations that has in healthy volunteers been able to mimic the circadian pattern of circulating cortisol was studied in patients with primary and secondary adrenal insufficiency.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Previously diagnosed (e. g. more than 6 months ago) primary or secondary adrenal

insufficiency with a stable daily glucocorticoid substitution dose for at least 3 months prior to study entry

- Signed informed consent to participate in the study

Exclusion Criteria:

- acute primary or secondary adrenal insufficiency

- clinical or laboratory signs of significant cerebral, cardiovascular, respiratory,

hepatobiliary, pancreatic disease

- clinically significant renal dysfunction

- any medication with agents which could interfere with glucocorticoid kinetics

Andrea M Isidori, MD, PhD, Phone: +3906499700540, Email: andrea.isidori@uniroma1.it

Department of Experimental Medicine, Rome 00161, Italy; Recruiting
Chiara Graziadio, MD,PhD, Phone: +390649970540, Email: chiaragraziadio@live.it
Andrea M Isidori, MD, PhD, Principal Investigator
Chiara Graziadio, MD, Sub-Investigator

Starting date: March 2014
Last updated: October 28, 2014