Acute effects of Sodium-glucose coTRansporter-2 inhibition on renal OxygeNation and AUTonomic function in type 1 diabetes - Astronaut

Steno Diabetes Center Copenhagen0 个研究点目标入组 30 人开始时间: 2020年1月2日最近更新: 2021年5月17日

适应症

试验速览

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•Inclusion criteria healthy controls:
•Written informed consent must be provided before participation
•Male or female patients >18 years of age with a diagnosis of type 1 diabetes (WHO criteria)
•Capable of lying in a MR-scanner for two hours
•Inclusion criteria persons with type 1 diabetes:
•Written informed consent must be provided before participation
•Male or female patients >18 years of age with a diagnosis of type 1 diabetes (WHO criteria)
•Urinary albumin creatinine ratio (UACR) =30 mg/g in 2 out of 3 consecutive samples (albuminuria) prior to randomization assessed from electronic laboratory database.
•Capable of lying in a MR-scanner for two hours
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Exclusion criteria for all:
•Non-diabetic kidney disease as indicated by medical history and/or laboratory findings
•Renal failure (eGFR<15 ml/min/1.73m2), dialysis or kidney transplantation
•Treatment with beta-blocking medication
•Uncontrolled arrhythmia, 2. or 3. degree AV-block or sick sinus syndrome - assessed from a standard 12-lead electrocardiogram
•Pregnancy or breastfeeding (urine HCG is performed on all fertile women)
•Systolic blood pressure < 90 or > 200 mmHg
•Patients who, in the judgement of the investigator, is incapable of participating
•Exclusion criteria for MRI
•o Claustrophobia
•o Known heart disease
•o Known lung disease
•o Have had surgery the past six weeks
•o Have foreign bodies of metal in the body (e.g. pacemaker, metal plates, metal screws)
•Exclusion criteria for arterial blood gas sampling
•o Absent pulse
•o Raynauds syndrome
•o Buergers Disease (thromboangiitis obliterans)
•o Inadequate or interrupted circulation
•o Anticoagulation treatment
•o Coagulopathies (hypo or hyper coagulable states)
•o Arterial atherosclerosis
•o Insufficient collateral perfusion
•o Partial or full thickness burns over the cannulation site
•o Synthetic arterial or vascular grafts or infection at the proposed site of cannulation

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