Colonic Motility in Patients With Diabetes

NCT04551625 | Unknown DMC

• 2 other identifiers: HRCM_3DT_DMEUDRAMED: CIV-20-05-032844
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Patients with DM and GI symptoms have reduced high-amplitude, antegrade contractions in the colon when compared to healthy controls (HRCM).
2. 2.Patients with DM and GI symptoms have reduced long, fast mass-movements when compared to healthy controls (3D-Transit).
3. 3.The contractile response to a meal is reduced in patients with symptoms of diabetic enteropathy when compared to healthy controls.

Conditions

Diabetes Mellitus

Keywords

Diabetic enteropathy; Neurogastroenterology; Colonic motility; High Resolution Colonic Manometry; 3D-Transit system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Long, fast mass-movements assessed with 3D-Transit

  All 24 hours of HRCM and 3D-Transit recording.

• Distance of capsule movement.

  All 24 hours of HRCM and 3D-Transit recording.

Interventions

High Resolution Colonic Manometry and 3D-Transit system. DEVICE

Not performed as an intervention, the study is observational.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

The Department og Hepatology and gastroenterology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Klaus Krogh, MD, ph.d.

  Overall scientific leadership of the protocol

  STUDY CHAIR

Central Study Contacts

Ditte S Iversen, MD

CONTACT

40517858; Dittiver@rm.dk

Klaus Krogh, MD, ph.d.

CONTACT

23385937; Klaukrog@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: October 15, 2020
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)