Clinical trial NCT04551625: Colonic Motility in Patients With Diabetes
Official title: Assessment of Colonic Motility in Patients With Diabetes Using High Resolution Colonic Manometry and 3D-Transit.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Keywords: Diabetic enteropathy
Neurogastroenterology
Colonic motility
High Resolution Colonic Manometry
3D-Transit system
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2020-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: High amplitude, antegrade contractions assessed with HRCM
timeFrame: All 24 hours of HRCM and 3D-Transit recording
Secondary outcomes:
measure: Long, fast mass-movements assessed with 3D-Transit
timeFrame: All 24 hours of HRCM and 3D-Transit recording.
measure: Distance of capsule movement.
timeFrame: All 24 hours of HRCM and 3D-Transit recording.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: The Department og Hepatology and gastroenterology, Aarhus University Hospital
Study officials:
affiliation: Overall scientific leadership of the protocol
name: Klaus Krogh, MD, ph.d.
role: STUDY_CHAIR
References: