Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT04193566
Eligibility Criteria:
Inclusion criteria healthy controls:
* Written informed consent must be provided before participation
* Male or female patients \> 18 years of age
* 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
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
* Claustrophobia
* Known heart disease
* Known lung disease
* Have had surgery the past six weeks
* Have foreign bodies of metal in the body (e.g. pacemaker, metal plates, metal screws)
* Exclusion criteria for arterial blood gas sampling (only patients with type 1 diabetes)
* Absent pulse
* Raynauds syndrome
* Buergers Disease (thromboangiitis obliterans)
* Inadequate or interrupted circulation
* Anticoagulation treatment
* Coagulopathies (hypo or hyper coagulable states)
* Arterial atherosclerosis
* Insufficient collateral perfusion
* Partial or full thickness burns over the cannulation site
* Synthetic arterial or vascular grafts or infection at the proposed site of cannulation Patients with type 1 diabetes will have the possibility to participate in the study without getting arterial blood gas sampling.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04193566
Study Brief:
Protocol Section:
NCT04193566