临床试验/2024-512100-19-00

2024-512100-19-00招募中4 期

Investigating cardiometabolic risk factors and changes in chronobiology patterns in patients with autonomous adrenal cortisol secretion

Medical University Of Vienna1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2024年10月14日最近更新: 2024年10月14日

试验速览

阶段: 4 期
状态: 招募中
发起方: Medical University Of Vienna
入组人数: 50
试验地点: 1
主要终点: Hepatic lipid content (HCL) assessed by 1H magnetic resonance spectroscopy

研究概览入排标准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

Cardiometabolic phenotyping of patients suffering from autonomous cortisol secretion and identifying a disease specific chronobiology profile in patients with altered hypothalamus-pituitary-adrenal (HPA) axis signaling

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: 是

入选标准

•Group autonomous cortisol secretion: Inclusion criteria for the ACS group: • Age > 18 years • History of an adrenal adenoma • morning cortisol > 1.8 ug/dl following 1 mg dexamethasone suppression test • No classical clinical features associated with the presence of Cushing’s syndrome, Control group: • Age > 18 years • History of an adrenal adenoma • morning cortisol of ≤ 1.8 ug/dl following 1 mg dexamethasone suppression testing

排除标准

•HbA1c > 8 % and/or treatment with insulin therapy 14 Proposal_AdrenalClock_V4 18.03.2023 • uncontrolled hypertension (RR > 170/110 mmHg; treatment with no more than 4 antihypertensive drugs) • previous treatment with glucocorticoids within the last 3 months • concomitant treatment with drugs affecting HPA signaling or CYP3A4 metabolism • adrenal tumor with radiological criteria suspicious for malignancy • chronic kidney disease (eGFR < 45 ml/min) • liver disease (ASAT / ALAT > 3 x ULN) • pregnancy or breast feeding • general MR contraindications (claustrophobia, metal devices or other magnetic material in the body which will be hazardous for MR investigation

结局指标

主要结局

Hepatic lipid content (HCL) assessed by 1H magnetic resonance spectroscopy

次要结局

insulin secretion and sensitivity based on validated indices (HOMA_IR, CLIX) • subcutaneous and visceral fat mass, body composition • Systolic and diastolic heart function, epicardial and pericardial fat mass • ectopic lipid deposition in the skeletal muscle and the myocardium • standardized blood pressure measurements (blood pressure for 24h hours and Schellong tests) • parameters of systemic inflammation (CRP, Il-6, PAI-1, TNF-alpha, homocysteine, leucocytes, monocytes)

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 Endocrinology and Metabolism

Scientific

Medical University Of Vienna

研究点 (1)

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