Colonic Motility in Patients With Diabetes

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: High Resolution Colonic Manometry and 3D-Transit system.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Ditte S Iversen, MD; Phone Number: 40517858; Email: Dittiver@rm.dk
• Study Contact Backup: Name: Klaus Krogh, MD, ph.d.; Phone Number: 23385937; Email: Klaukrog@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • The Department og Hepatology and gastroenterology, Aarhus University Hospital
    • Contact: Ditte S Iversen, MD; Phone Number: 40517858; Email: Dittiver@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All individuals who meet the inclusion- and exclusion criteria can be enrolled in the study. The recruitment process will primarily take place through the outpatient clinics at Aarhus University Hospital.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aalborg University Hospital
• Investigators: Study Chair: Klaus Krogh, MD, ph.d., Overall scientific leadership of the protocol

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2020
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): October 15, 2022

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Colonic motility; Diabetic enteropathy; Neurogastroenterology; High Resolution Colonic Manometry; 3D-Transit system
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: HRCM_3DT_DM; EUDRAMED: CIV-20-05-032844 (Other Identifier: Danish Medicines Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No