Colonic Motility in Patients With Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Assessment of Colonic Motility in Patients With Diabetes Using High Resolution Colonic Manometry and 3D-Transit.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04551625
• Other study ID #: HRCM_3DT_DM
• Secondary ID: EUDRAMED: CIV-20
• Status: Not yet recruiting
• Start date: October 15, 2020
• Est. completion date: October 15, 2022

Study information

• Verified date: September 2020
• Source: University of Aarhus
• Contact: Ditte S Iversen, MD
• Phone: 40517858
• Email: Dittiver[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• High Resolution Colonic Manometry and 3D-Transit system.
Not performed as an intervention, the study is observational.

Locations

Country	Name	City	State
Denmark	The Department og Hepatology and gastroenterology, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High amplitude, antegrade contractions assessed with HRCM	Quantity, amplitude and duration of the high amplitude, antegrade propagating contractions accessed with HRCM, when compared to healthy controls.	All 24 hours of HRCM and 3D-Transit recording
Secondary	Long, fast mass-movements assessed with 3D-Transit	Quantity and length of the long, fast mass-movements assessed with 3D-Transit, when compared to healthy controls.	All 24 hours of HRCM and 3D-Transit recording.
Secondary	Distance of capsule movement.	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).	All 24 hours of HRCM and 3D-Transit recording.