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Treatment of Complications to Diabetic Autonomic Neuropathy With Vagus Nerve Stimulation

2019-11-03 15:10:58 | BioPortfolio

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 type 2 diabetes.

Description

The study is a randomized, double-blinded, sham-controlled, parallel group clinical trial, which will include participants with type 2 diabetes and gastrointestinal (GI) problems. These problems may be manifestations of diabetic autonomic neuropathy.

Participants are randomised to received either active non-invasive transcutaneous vagal nerve stimulation (tVNS) or inactive sham stimulation. The study period is divided in two phases. The first phase investigates the effects of short-term, high-intensity tVNS treatment on GI symptoms. The second phase investigates the effects of long-term, middle-intensity tVNS treatment. The primary outcome of both phases is subjective patient evaluation of GI symptoms by the use of validated questionnaires.

A third phase, conducted only on participants, who proved to be responsive to tVNS treatment, will investigate the acute endocrine and metabolic response to short-term tVNS in a randomised cross-over design.

Lastly, healthy volunteers will be included in a cross-sectional, descriptive study in order to provide a comparable baseline dataset.

Study Design

Conditions

Diabetes Mellitus, Type 2

Intervention

Non-invasive transcutaneous vagus nerve stimulation, Sham vagus nerve stimulation

Status

Not yet recruiting

Source

Aalborg University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-03T15:10:58-0500

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Medical and Biotech [MESH] Definitions

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