NCT04143269

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

3 years

First QC Date

October 22, 2019

Last Update Submit

June 6, 2023

Conditions

Gastrointestinal DysfunctionDiabetes Mellitus

Keywords

Vagal nerve stimulationGastrointestinal symptomsDiabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Subjective gastrointestinal symptoms

    Assessed as changes from baseline in scores from the validated questionnaire Gastroparesis Cardinal Symptom Index (GCSI). The GCSI-score ranges from 0 to 5 with a higher score indicating a higher amount of experienced symptoms

    At baseline and after 7 days (period 1) and 8 weeks (period 2) of intervention

  • Subjective gastrointestinal symptoms

    Assessed as changes from baseline in scores from the validated questionnaire Gastrointestinal Symptom Rating Scale (GSRS). The GSRS-score ranges from 1 to 7 with a higher score indicating a higher amount of experienced symptoms

    At baseline and after 7 days (period 1) and 8 weeks (period 2) of intervention

Secondary Outcomes (16)

  • Holter monitoring

    At baseline and after 7 days (period 1) of intervention

  • Cardiac vagal tone

    At baseline and after 7 days (period 1) of intervention

  • Cardiovascular reflex testing

    At baseline and after 7 days (period 1) of intervention

  • Sudomotor function

    At baseline and after 7 days (period 1) of intervention

  • Pan-intestinal imaging

    At baseline and after 7 days (period 1) of intervention

  • +11 more secondary outcomes

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Non-invasive transcutaneous vagus nerve stimulation applied by the GammaCore device (ElectroCore LLC)

Device: Non-invasive transcutaneous vagus nerve stimulation

Sham Treatment

SHAM COMPARATOR

Inactive sham vagus nerve stimulation applied by the GammaCore sham device (ElectroCore LLC)

Device: Sham vagus nerve stimulation

Interventions

Non-invasive transcutaneous vagus nerve stimulationDEVICE

Bilateral stimulation 4 times per day for 7 days (period 1) and 2 times per day for 8 weeks (period 2). The two periods are separated by a 2 weeks wash-out period.

Also known as: GammaCore device
Active treatment
Sham vagus nerve stimulationDEVICE

Bilateral stimulation 4 times per day for 7 days (period 1) and 2 times per day for 8 weeks (period 2). The two periods are separated by a 2 weeks wash-out period. The sham device produces a slight vibrating sensation, but do not provide any vagal nerve activation

Also known as: GammaCore sham device
Sham Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant GI diseases not related to diabetes
  • Significant cardiovascular diseases
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center North Jutland

Aalborg, 9000, Denmark

Location

Related Publications (2)

  • Kornum DS, Bertoli D, Kufaishi H, Wegeberg AM, Okdahl T, Mark EB, Hoyer KL, Frokjaer JB, Brock B, Krogh K, Hansen CS, Knop FK, Brock C, Drewes AM. Transcutaneous vagal nerve stimulation for treating gastrointestinal symptoms in individuals with diabetes: a randomised, double-blind, sham-controlled, multicentre trial. Diabetologia. 2024 Jun;67(6):1122-1137. doi: 10.1007/s00125-024-06129-0. Epub 2024 Mar 28.

    PMID: 38546822DERIVED

  • Okdahl T, Bertoli D, Brock B, Krogh K, Knop FK, Brock C, Drewes AM. 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. BMJ Open. 2021 Jan 6;11(1):e038677. doi: 10.1136/bmjopen-2020-038677.

    PMID: 33408197DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Asbjørn M Drewes, Professor

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professir, Chief Physician, MD, PhD, DMSc

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 29, 2019

Study Start

January 20, 2020

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Data can be provided upon request.

Time Frame
From study end. No end date
Access Criteria
Researchers who provide a methodological sound proposal

Locations

DK(1)