NCT04143269 - Treatment of Complications to Diabetic Autonomic Neuropathy With Vagus Nerve Stimulation | Biotech Hunter

Enrollment

120

Participants

Timeline

Start Date

January 20, 2020

Primary Completion Date

February 1, 2023

Study Completion Date

February 1, 2023

Conditions

Gastrointestinal DysfunctionDiabetes Mellitus

Interventions

DEVICE

Non-invasive transcutaneous vagus nerve stimulation

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.

DEVICE

Sham vagus nerve stimulation

"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"

Trial Locations (1)

9000

Steno Diabetes Center North Jutland, Aalborg