Diabetes Mellitus Clinical Trial
Official title:
Assessment of Colonic Motility in Patients With Diabetes Using High Resolution Colonic Manometry and 3D-Transit.
Background:
Gastrointestinal (GI) symptoms are overrepresented in patients with diabetes mellitus (DM)
and often have a major impact on quality of life. Typical symptoms of diabetic enteropathy
include abdominal pain, nausea, vomiting, diarrhoea, constipation, faecal incontinence, and
bloating. Bowel symptoms in DM are usually caused by widespread dysfunction of the GI tract,
but the exact pathophysiology remains incompletely understood. Within recent years, new
methods for detailed assessment of GI motility have been developed. Hence, the
electromagnetic 3D-Transit system is a safe, non-invasive method for detailed description of
GI motility. The system tracks the exact position of an ingested electromagnetic capsule
through the entire GI tract and provides detailed information on both regional transit- and
contraction patterns. High Resolution Colonic Manometry (HRCM) allows extremely detailed
description of contraction patterns in the colon. The HRCM is however an invasive method, as
the catheter is placed during colonoscopy. HRCM has not previously been performed on diabetic
patients and 3D-Transit has only been used sparingly.
Study Objectives:
The purpose of this study is to obtain detailed description of colonic contractions in
patients with DM and gastrointestinal symptoms, especially during fast and after meals.
Hypothesis:
1. Patients with DM and GI symptoms have reduced high-amplitude, antegrade contractions in
the colon when compared to healthy controls (HRCM).
2. Patients with DM and GI symptoms have reduced long, fast mass-movements when compared to
healthy controls (3D-Transit).
3. The contractile response to a meal is reduced in patients with symptoms of diabetic
enteropathy when compared to healthy controls.
Materials and methods:
20 patients with DM type 1 or 2 and GI symptoms will be investigated simultaneously HCRM and
the 3D-Transit capsule. Data will be compared to the healthy from another study
(CIV-19-05-028726). A colonoscopy is performed to install the HRCM catheter and place two
3D-Transit capsules within the colon. For 24 hours, the participants lie in a bed in the
research lab while pressure changes from the HRCM catheter are recorded and the 3D-Transit
capsules are followed through the gastrointestinal system.
Perspectives:
The study will add to the very limited data available on colonic dysfunction in DM.
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