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
; 11(1): e038677, 2021 01 06.
Article
en En
| MEDLINE
| ID: mdl-33408197
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 ANDANALYSIS:
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.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Estimulación Eléctrica Transcutánea del Nervio
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Diabetes Mellitus
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Neuropatías Diabéticas
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Estimulación del Nervio Vago
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Guideline
Límite:
Humans
Idioma:
En
Revista:
BMJ Open
Año:
2021
Tipo del documento:
Article
País de afiliación:
Dinamarca