Treatment of Complications to Diabetic Autonomic Neuropathy With Vagus Nerve Stimulation (NCT04143269) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Complications to Diabetic Autonomic Neuropathy With Vagus Nerve Stimulation
Denmark120 participantsStarted 2020-01-20
Plain-language summary
The purpose of the DAN-VNS study is to investigate the effects of non-invasive vagal nerve stimulation on gastrointestinal symptoms such as nausea, vomiting, bloating, and diarrhea in people with diabetes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Verified diagnosis of diabetes for a minimum of 1 year and with stable medication
* CAN-score ≥ 1 (measured by the Vagus device (Medicus Engineering, Aarhus, Denmark) OR COMPASS-31 score of ≥ 16 OR electrochemical resistance \<50µS (hands) and \<70µS (feet) assessed with the SUDOSCAN device
* Weighted composite score of Gastroparesis Cardinal Symptom Index (GCSI) and Gastrointestinal Symptom Rating Scale (GSRS) ≥ 2.3
* Ability to read and understand Danish
* Personally signed and dated informed consent documents
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
Exclusion Criteria:
* Significant GI diseases not related to diabetes
* Significant cardiovascular diseases
* GI surgery within 3 months prior to study inclusion
* Swallowing disorders
* Blood pressure \< 100/60 or \> 160/105
* Clinically significant bradycardia or tachycardia
* Implanted portable electro-mechanical medical devices including pacemaker, defibrillator, cochlear implant, and infusion pump
* Previous surgery of the vagus nerve
* Active laser treatment for proliferative retinopathy
* Contraindications for MRI
* Any clinical abnormalities, that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results
* Pregnancy or intention to become pregnant or father a child during the course of the study
* Participa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subjective gastrointestinal symptoms
Timeframe: At baseline and after 7 days (period 1) and 8 weeks (period 2) of intervention
2
Subjective gastrointestinal symptoms
Timeframe: At baseline and after 7 days (period 1) and 8 weeks (period 2) of intervention