Primary Adrenal Insufficiency Clinical Trial
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.
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.
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.
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