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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Roma La Sapienza

Current Primary Outcome: Change from baseline in measurement of weight at 3 and 6 months [ Time Frame: 0, + 3 months, + 6 months ]

Single outcome measurement of body weight (kg).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in metabolic status at 3 and 6 months [ Time Frame: 0, + 3 months, + 6 months ]
    Composite outcome measure consisting of simultaneous measurment of: Glycaemia, Insulinemia, Homa index, Glycated Haemoglobin, Total Cholesterol, LDL cholesterol, HDL cholesterol, Triglyceredes; the composite outcome measured at 3 and 6 months.
  • Evaluation of immunological profile at baseline 3 and 6 months. [ Time Frame: 0, + 3 months, + 6 months ]
    Composite outcome measure consisting of simultaneous measurment of: Full Count Blood Cell, ESR, Fibrinogen, Immunoglobulin, PCR; measured at baseline, 3 and 6 months.
  • Evaluation of bone deposition and resorption markers from baseline at 6 months [ Time Frame: 0, + 6 months ]
    Composite outcome measure consisting of simultaneous measurment of: serum calcium, phosphate, parathyroid hormone (PTH), 25OH-vitamin D, phosphate, osteocalcin, bone phosphate alkaline (sBALP), serum-cross-linked N and C-telopeptide of bone type I collagen (NTx- CTx); measure at baseline and 6 months.
  • Evaluation of epicardial fat thickness from baseline at 6 months [ Time Frame: 0, + 6 months ]
    Measurement of epicardial fat thickness (EFT) by hihg-resolution M-B-mode transthoracic echocardiography from baseline at 6 months.
  • Evaluation of hepatic steatosis from baseline at 6 months [ Time Frame: 0, + 6 months ]
    Evaluation of hepatic steatosis by conventional ultrasound of the liver and with ASQ software with dedicated equipment and 7-5 Mhz convex probe frome baseline at 6 months.
  • Changes in quality of life from baseline at 2, 3 and 6 months [ Time Frame: 0, + 2 months, +3 months, + 6 months ]
    Quality of life will be measured by questionnaires: AddiQol, Middle Sex Hospital Questionnaire (MHQ), International Index of Erectile Function (IIEF), Female Sexual Function Index (FSFI), Beck Depression Inventory Test (BDI-II), Morisky Questionnaire.
  • Bone mineral density [ Time Frame: 0, + 6 months ]
    Bone mineral density quantified by Dual X-Ray Absorptiometry (DEXA)


Original Secondary Outcome: Same as current

Information By: University of Roma La Sapienza

Dates:
Date Received: October 24, 2014
Date Started: March 2014
Date Completion: June 2016
Last Updated: October 28, 2014
Last Verified: October 2014