Study of Autonomic and Gastrointestinal Function in Patients Suffering From Diabetes with Gastrointestinal Symptoms Treated With Vagus Nerve Stimulation
Authors
Sørensen, Peter Skjødt ; Nissen, Marcus Reenberg
Term
5. Term (Master thesis)
Education
Publication year
2022
Abstract
Diabetisk autonom neuropati kan give svær gastroenteropati, og eksisterende behandlinger er ofte utilstrækkelige. Denne multicenter, randomiserede, parallelgruppe, placebokontrollerede undersøgelse vurderer, om transkutan vagusnervestimulation (tVNS) kan lindre gastrointestinale symptomer og påvirke autonom funktion hos personer med type 1 eller 2-diabetes, autonome forstyrrelser og betydelige mave-tarmsymptomer. I den foreløbige analyse blev 52 deltagere randomiseret 1:1 til aktiv eller sham tVNS (GammaCore), givet bilateralt fire gange dagligt i syv dage. Primære endepunkter var symptomændringer målt med Gastroparesis Cardinal Symptom Index (GCSI) og Gastrointestinal Symptom Rating Scale (GSRS); sekundære endepunkter omfattede blodtryk, puls, kardial vagustonus, elektrokemisk sudomotorisk funktion og Cardiac Autonomic Neuropathy-score. Vurderinger blev udført ved baseline og efter syv dage. Studiet er fortsat blindet til, hvilken arm der er aktiv, og resultaterne er rapporteret som behandling A vs. B. Behandling B gav en større reduktion i GCSI fra baseline end behandling A (-0,9 vs. -0,3; p=0,01), inklusive signifikante forbedringer i kvalme (p=0,05) og tidlig mæthed (p=0,02), mens øvrige mål ikke viste signifikante forskelle. Hvis B er aktiv tVNS, tyder det på, at tVNS kan lindre gastrointestinale symptomer over syv dage; hvis B er sham, peger resultaterne på en robust placeboreaktion og ingen overlegen effekt af tVNS. Manglende ændringer i autonome mål og den korte behandlingsvarighed understreger behovet for længere opfølgning og fuld afblinding, før endelige konklusioner kan drages.
Diabetic autonomic neuropathy can cause severe gastroenteropathy, and current treatments are often inadequate. This multicenter, randomized, parallel-group, placebo-controlled trial evaluates whether transcutaneous vagus nerve stimulation (tVNS) can relieve gastrointestinal symptoms and affect autonomic function in people with type 1 or type 2 diabetes, autonomic dysfunction, and prominent GI symptoms. In the preliminary analysis, 52 participants were randomized 1:1 to active or sham tVNS (GammaCore), delivered bilaterally four times daily for seven days. Primary outcomes were symptom changes measured by the Gastroparesis Cardinal Symptom Index (GCSI) and the Gastrointestinal Symptom Rating Scale (GSRS); secondary outcomes included blood pressure, heart rate, cardiac vagal tone, electrochemical sudomotor function, and the Cardiac Autonomic Neuropathy score. Assessments were performed at baseline and after seven days. The study remains blinded as to which arm is active, and results are reported as treatment A vs. B. Treatment B produced a greater reduction in GCSI from baseline than treatment A (-0.9 vs. -0.3; p=0.01), with significant improvements in nausea (p=0.05) and early satiety (p=0.02), while other measures showed no significant differences. If B is active tVNS, these findings suggest tVNS may alleviate GI symptoms over seven days; if B is sham, they indicate a robust placebo response with no superiority of tVNS. The absence of significant changes in autonomic measures and the short treatment duration highlight the need for longer follow-up and full unblinding before drawing definitive conclusions.
[This summary has been generated with the help of AI directly from the project (PDF)]
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