Colonic Motility in Patients With Diabetes

NCT ID: NCT04551625

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2022-10-15

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.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

High Resolution Colonic Manometry and 3D-Transit system.

Not performed as an intervention, the study is observational.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Klaus Krogh, MD, ph.d.

Role: STUDY_CHAIR

Overall scientific leadership of the protocol

Locations

The Department og Hepatology and gastroenterology, Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Central Contacts

Ditte S Iversen, MD

Role: CONTACT

Dittiver@rm.dk

40517858

Klaus Krogh, MD, ph.d.

Role: CONTACT

Klaukrog@rm.dk

23385937

Facility Contacts

Ditte S Iversen, MD

Role: primary

Dittiver@rm.dk

40517858

Other Identifiers

EUDRAMED: CIV-20-05-032844

Identifier Type: OTHER

Identifier Source: secondary_id

HRCM_3DT_DM

Identifier Type: -

Identifier Source: org_study_id