临床试验/2026-526837-24-00

2026-526837-24-00招募中4 期

A prospective, randomized, double-blinded, placebo-controlled, cross-over study investigating the effects of metyrapone treatment on cardio-metabolic outcome parameters and chronobiology in patients with mild autonomous cortisol secretion

Medical University Of Vienna1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2026年10月1日最近更新: 2026年8月29日

适应症

干预措施

试验速览

阶段: 4 期
状态: 招募中
发起方: Medical University Of Vienna
入组人数: 40
试验地点: 1
主要终点: Hepatic lipid content

研究概览入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Aim 1 - Investigating the effects of evening doses of metyrapone on the cardio-metabolic phenotype in patients with mild autonomous cortisol secretion. Aim 2 - Investigating the effects of evening doses of metyrapone on chronobiology in patients with mild autonomous cortisol secretion

入排标准

年龄范围: 18 years 至 65+ years（18-64 Years, 65+ Years）
接受健康志愿者: 否

入选标准

•Men and women aged 18-80 years; >1.8 µg/dl serum cortiMen and women aged 18-80 years • >1.8 µg/dl serum cortisol after 1mg DST; Presence of adrenal adenomasol after 1mg DST;Presence of adrenal adenoma

排除标准

•Clinical signs of Cushing’s syndrome: facial plethora, dorsocervical fat pad, purple striae, easy bruising or proximal muscular atrophy;radiological signs suspect of malignancy;concomitant pheochromocytoma or primary hyperaldosteronism;ongoing antidiabetic treatment with sulfonylurea or insulin;previous glucocorticoid treatment within 3 months prior to study related activities; advanced chronic kidney and liver disease;concomitant treatment with drugs strongly interacting with CYP3A4 • concomitant treatment with drugs known to effect circulating serum cortisol concentrations (i.e. estrogen based oral contraception,…)

研究组 & 干预措施

Metycor 250 mg Weichkapseln

Test

干预措施: Metycor 250 mg Weichkapseln (Drug)

Placebo

干预措施: Placebo (Drug)

Hydrocortison 10 mg JENAPHARM

Auxiliary

干预措施: Hydrocortison 10 mg JENAPHARM (Drug)

结局指标

主要结局

Hepatic lipid content

次要结局

insulin sensitivity (HOMA-IR, OGIS);insulin secretion (Insulinogenic Index);ambulatory systolic and diastolic blood pressure (mean of 5 measurements during 10 minutes in supine position);parameters of systemic inflammation (leukocyte count, neutrophil count, lymphocyte count, monocyte count; leucocyte /neutrophile ratio, leucocyte / lymphocyte ratio)

研究者

发起方

Medical University Of Vienna

申办方类型

Educational Institution

责任方

Principal Investigator

主要研究者

Department of Medicine III, Division of Endocrinology and Metabolism

Scientific

Medical University Of Vienna

研究点 (1)

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