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NCT04143269: DAN-VNS
Treatment of Complications to Diabetic Autonomic Neuropathy With Vagus Nerve Stimulation
Completed
NA
Last updated 7 June 2023
What this trial tests
NA trial testing Non-invasive transcutaneous vagus nerve stimulation in Gastrointestinal Dysfunction in 120 participants. Completed in 1 February 2023.
Timeline
20 January 2020
Primary endpoint
1 February 2023
1 February 2023
1 February 2023
Quick facts
| Lead sponsor | Aalborg University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 20 January 2020 |
| Primary completion | 1 February 2023 |
| Estimated completion | 1 February 2023 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Non-invasive transcutaneous vagus nerve stimulation
- Sham vagus nerve stimulation
Conditions studied
- Gastrointestinal Dysfunction — all drugs for Gastrointestinal Dysfunction →
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
Sponsor
Aalborg University Hospital
Who can join
18 and older, any sex, with Gastrointestinal Dysfunction or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Study protocol for a multicentre, randomised, parallel group, sham-controlled clinical trial investigating the effect of transcutaneous vagal nerve stimulation on gastrointestinal symptoms in people with diabetes complicated with diabetic autonomic neuropathy: the DAN-VNS Study.
Okdahl T, Bertoli D, Brock B, Krogh K, et al · · 2021 · cited 18× · PMID 33408197 · DOI 10.1136/bmjopen-2020-038677 -
Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124 -
Transcutaneous vagal nerve stimulation for treating gastrointestinal symptoms in individuals with diabetes: a randomised, double-blind, sham-controlled, multicentre trial.
Kornum DS, Bertoli D, Kufaishi H, Wegeberg AM, et al · · 2024 · cited 12× · PMID 38546822 · DOI 10.1007/s00125-024-06129-0 -
Diabetic gastroenteropathy: Associations between gastrointestinal symptoms, motility, and extraintestinal autonomic measures.
Kornum DS, Brock C, Okdahl T, Bertoli D, et al · · 2026 · cited 9× · PMID 39485948 · DOI 10.1111/nmo.14956 -
MRI-Based Quantification of Pan-Alimentary Function and Motility in Subjects with Diabetes and Gastrointestinal Symptoms.
Bertoli D, Mark EB, Liao D, Okdahl T, et al · · 2023 · cited 7× · PMID 37762909 · DOI 10.3390/jcm12185968 -
Transcutaneous vagus nerve stimulation has no anti-inflammatory effect in diabetes.
Okdahl T, Kufaishi H, Kornum D, Bertoli D, et al · · 2024 · cited 3× · PMID 39251831 · DOI 10.1038/s41598-024-72139-y -
Glycaemic control, low levels of high-density lipoprotein, and high cardiovascular risk are associated with cardiovascular autonomic neuropathy.
Okdahl T, Wegeberg AM, Jensen MM, Quist JS, et al · · 2025 · cited 2× · PMID 40759964 · DOI 10.1186/s13098-025-01834-1 -
Panenteric Transit Times and Contractile Activity in Diabetic Gastroenteropathy.
Kornum DS, Brock C, Okdahl T, Bertoli D, et al · · 2025 · cited 1× · PMID 40205900 · DOI 10.5056/jnm24126
Verify or expand the search:
- PubMed search for NCT04143269
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04143269 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aalborg University Hospital
- Last refreshed: 7 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04143269.
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