Colonic Motility in Patients With Diabetes

• Conditions: Diabetes Mellitus

• Registration Number: NCT04551625
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16
• Study Start: 2020-10-15
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Type 1 or 2 diabetes (at least 3 years since diagnosis)
• Age between 18 and 70
• Gastrointestinal symptoms with a weighted and combined symptomscore >2,3 (assessed with The Gastrointestinal Symptom Rating Scale and The Gastroparesis Cardinal Symptom Score).
• Psychologically able to give an informed content.

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Exclusion Criteria

• Known gastrointestinal disease
• Intake of medication with known effects on the motility patterns in the gastrointestinal system.
• Dysregulated hyperthyroidism or hypothyroidism.
• Any disease known to cause gastroparesis (Parkinson's disease, scleroderma, etc.)
• Pacemaker/ICD
• A scheduled MRI scan within 4 weeks after trial initiation.
• Abdominal circumference >140cm
• Pregnancy and lactation
• Unable to follow the scheduled program in the trial due to mental illness or instability.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High amplitude, antegrade contractions assessed with HRCM	All 24 hours of HRCM and 3D-Transit recording	Quantity, amplitude and duration of the high amplitude, antegrade propagating contractions accessed with HRCM, when compared to healthy controls.

Secondary Outcome Measures

Name	Time	Method
Long, fast mass-movements assessed with 3D-Transit	All 24 hours of HRCM and 3D-Transit recording.	Quantity and length of the long, fast mass-movements assessed with 3D-Transit, when compared to healthy controls.
Distance of capsule movement.	All 24 hours of HRCM and 3D-Transit recording.	How do the length of a pressure change measured by HRCM correlate with the distance covered in long fast antegrade movements determined with the 3D-Transit system (cm).

Trial Locations

Locations (1)

The Department og Hepatology and gastroenterology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark