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

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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, Tina; Bertoli, Davide; Brock, Birgitte et al.

In: BMJ Open, Vol. 11, No. 1, e038677, 01.2021.

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@article{b41660d7e1e94e45a0f2105e4111cd3f,
title = "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",
abstract = "INTRODUCTION: A high proportion of people with diabetes experience gastrointestinal (GI) symptoms, which may be manifestations of diabetic autonomic neuropathy (DAN). The current treatment regime is ineffective and associated with major side effects. Transcutaneous vagal nerve stimulation (tVNS) is a new therapeutic option, which has been shown to increase GI motility and reduce inflammatory responses. As vagus is the main neuronal pathway for extrinsic coordination of GI secretion and motility, we hypothesise that tVNS will improve DAN-induced GI symptoms in subjects with diabetes.METHODS AND ANALYSIS: The DAN-VNS study is a randomised multicentre clinical trial investigating the effect of short-term, high intensity as well as long-term, medium-intensity tVNS on GI symptom alleviation in 120 subjects with diabetes. The primary outcome consists of changes from baseline in subjective ratings of symptom severity. Secondary outcomes include changes in gastric motility and GI transit time measured by MRI and wireless motility capsule. Moreover, cardiovascular and sudomotor function, glycaemic control, brain sensory processing and presence of low-grade inflammation will be investigated as secondary outcome measures. Lastly, 15 responders of tVNS treatment will be included in an explorative, randomised, cross-over study, in which the acute endocrine and metabolic response to short-term tVNS will be investigated.ETHICS AND DISSEMINATION: The study has been approved by the North Denmark Region Committee on Health Research Ethics (N-20190020). Results will be published in relevant international peer-reviewed journals.TRIAL REGISTRATION NUMBER: NCT04143269.",
keywords = "Cross-Over Studies, Diabetes Mellitus, Diabetic Neuropathies/therapy, Humans, Magnetic Resonance Imaging, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Transcutaneous Electric Nerve Stimulation, Vagus Nerve Stimulation",
author = "Tina Okdahl and Davide Bertoli and Birgitte Brock and Klaus Krogh and {Krag Knop}, Filip and Christina Brock and Drewes, {Asbj{\o}rn M}",
year = "2021",
month = jan,
doi = "10.1136/bmjopen-2020-038677",
language = "English",
volume = "11",
journal = "B M J Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "1",

}

RIS

TY - JOUR

T1 - 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

T2 - the DAN-VNS Study

AU - Okdahl, Tina

AU - Bertoli, Davide

AU - Brock, Birgitte

AU - Krogh, Klaus

AU - Krag Knop, Filip

AU - Brock, Christina

AU - Drewes, Asbjørn M

PY - 2021/1

Y1 - 2021/1

N2 - INTRODUCTION: A high proportion of people with diabetes experience gastrointestinal (GI) symptoms, which may be manifestations of diabetic autonomic neuropathy (DAN). The current treatment regime is ineffective and associated with major side effects. Transcutaneous vagal nerve stimulation (tVNS) is a new therapeutic option, which has been shown to increase GI motility and reduce inflammatory responses. As vagus is the main neuronal pathway for extrinsic coordination of GI secretion and motility, we hypothesise that tVNS will improve DAN-induced GI symptoms in subjects with diabetes.METHODS AND ANALYSIS: The DAN-VNS study is a randomised multicentre clinical trial investigating the effect of short-term, high intensity as well as long-term, medium-intensity tVNS on GI symptom alleviation in 120 subjects with diabetes. The primary outcome consists of changes from baseline in subjective ratings of symptom severity. Secondary outcomes include changes in gastric motility and GI transit time measured by MRI and wireless motility capsule. Moreover, cardiovascular and sudomotor function, glycaemic control, brain sensory processing and presence of low-grade inflammation will be investigated as secondary outcome measures. Lastly, 15 responders of tVNS treatment will be included in an explorative, randomised, cross-over study, in which the acute endocrine and metabolic response to short-term tVNS will be investigated.ETHICS AND DISSEMINATION: The study has been approved by the North Denmark Region Committee on Health Research Ethics (N-20190020). Results will be published in relevant international peer-reviewed journals.TRIAL REGISTRATION NUMBER: NCT04143269.

AB - INTRODUCTION: A high proportion of people with diabetes experience gastrointestinal (GI) symptoms, which may be manifestations of diabetic autonomic neuropathy (DAN). The current treatment regime is ineffective and associated with major side effects. Transcutaneous vagal nerve stimulation (tVNS) is a new therapeutic option, which has been shown to increase GI motility and reduce inflammatory responses. As vagus is the main neuronal pathway for extrinsic coordination of GI secretion and motility, we hypothesise that tVNS will improve DAN-induced GI symptoms in subjects with diabetes.METHODS AND ANALYSIS: The DAN-VNS study is a randomised multicentre clinical trial investigating the effect of short-term, high intensity as well as long-term, medium-intensity tVNS on GI symptom alleviation in 120 subjects with diabetes. The primary outcome consists of changes from baseline in subjective ratings of symptom severity. Secondary outcomes include changes in gastric motility and GI transit time measured by MRI and wireless motility capsule. Moreover, cardiovascular and sudomotor function, glycaemic control, brain sensory processing and presence of low-grade inflammation will be investigated as secondary outcome measures. Lastly, 15 responders of tVNS treatment will be included in an explorative, randomised, cross-over study, in which the acute endocrine and metabolic response to short-term tVNS will be investigated.ETHICS AND DISSEMINATION: The study has been approved by the North Denmark Region Committee on Health Research Ethics (N-20190020). Results will be published in relevant international peer-reviewed journals.TRIAL REGISTRATION NUMBER: NCT04143269.

KW - Cross-Over Studies

KW - Diabetes Mellitus

KW - Diabetic Neuropathies/therapy

KW - Humans

KW - Magnetic Resonance Imaging

KW - Multicenter Studies as Topic

KW - Randomized Controlled Trials as Topic

KW - Transcutaneous Electric Nerve Stimulation

KW - Vagus Nerve Stimulation

U2 - 10.1136/bmjopen-2020-038677

DO - 10.1136/bmjopen-2020-038677

M3 - Journal article

C2 - 33408197

VL - 11

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 1

M1 - e038677

ER -