Dual-release hydrocortisone compared to immediate-release glucocorticoid replacement therapy in terms of glucose control, insulin sensitivity and glucose variability in patients with adrenal insufficiency and concomitant diabetes mellitus. - Dual-release hydrocortisone compared to immediate-release glucocorticoid replacement therapy in pati

AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA0 个研究点目标入组 16 人开始时间: 2021年6月8日最近更新: 2022年3月14日

试验速览

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•The inclusion criteria for the participants in this study are as follows:
•Males and females older than 18 years up to 90 years of age (women of childbearing age they will perform a high sensitivity pregnancy test to exclude a pregnancy before being included in the study);
•diagnosis of primitive or secondary adrenal insufficiency;
•Stable substitution treatment (same dosage and same active principle) with glucorticoids for at least 6 months;
•- Substitution treatment with L-thyroxin and / or fludrocortisone stable at least 3 months before
•Concomitant diagnosis of DMT1 or DMT2, in multiinjection insulin therapy or with Oral hypoglycemic agents.
•Affected at the Hospitals' Diabetes / Endocrinology Outpatient Clinic University of Verona;
•optimization of metabolic control prior to entry into the study in the presence of clinically stable HbA1c values ¿¿(variations of less than 0.3%) in the two controls prior to recruitment, spaced at least 3 months apart;
•Signature of informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•Subjects will be excluded from the study with the following characteristics:
•- Pregnant women or fertile age in extroprogestine therapy for contractual purposes;
•- breastfeeding women;
•- subjects with hypersensitivity to the active substance or to any of the excipients
•- Gastrointestinal motility disorders;
•- Adrenal insufficiency secondary to the suspension of chronic steroid treatment;
•Cortical-adrenal carcinoma
•- Coexistence of other pathologies that may require a treatment cycle high doses of steroids.

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