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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT04625751
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of type 2 diabetes (Patients)
* Age between 50-70 years (All)
* Presence of CAN as diagnosed by cardiovascular reflex tests with two or three pathological results (Patients with CAN only)
* Exclusion of CAN as diagnosed by cardiovascular reflex tests with no pathological results (Patients without CAN and HC only)
Exclusion Criteria:
* Participants receiving treatment with direct effects on noradrenergic or cholinergic signaling (for example beta-blockers, tricyclic antidepressants, SSRI's) (All)
* Acute infections (All)
* Thyroid disease (All)
* Substance or alcohol abuse (All)
* Atrial fibrillation or flutter (All)
* Respiratory failure (All)
* Participants in active laser treatment for retinopathy, will be excluded from the Valsalva test (Patients)
* Non-diabetic causes of neuropathy including a medical history of vitamin B12 deficiency, folic acid deficiency, rheumatoid arthritics, amyloidosis, HIV, syphilis, Borreliosis, drug induced neuropathy and neuropathy caused by toxins (All)
* Claustrophobia (All)
* Implanted pacemakers or remaining pacemaker electrodes (All)
* Previous heart or brain surgery with use of metal clips (All)
* Any form of non-MR-compatible implants
* Non-compliance with the study protocol as judged by the investigators (All)
* Concurrent participation in an intervention study (Patients)
* Participants who by judgments of the investigator, is incapable of participating (All)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT04625751
Study Brief:
Protocol Section:
NCT04625751