Diabetes MellitusNCT04551625
Colonic Motility in Patients With Diabetes
An observational study of Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- High Resolution Colonic Manometry and 3D-Transit system.
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2020to 15 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Abdominal circumference >140cm
- Pregnancy and lactation
- Unable to follow the scheduled program in the trial due to mental illness or instability.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Department og Hepatology and gastroenterology, Aarhus University Hospital
Aarhus, 8200
Ditte S Iversen, MD, 40517858, Dittiver@rm.dk
About this study
Official title: 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.
Read more
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:
- Patients with DM and GI symptoms have reduced high-amplitude, antegrade contractions in the colon when compared to healthy controls (HRCM).
- Patients with DM and GI symptoms have reduced long, fast mass-movements when compared to healthy controls (3D-Transit).
- 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
- Being tested
- High Resolution Colonic Manometry and 3D-Transit system.
- Keywords
- Diabetic enteropathy, Neurogastroenterology, Colonic motility, High Resolution Colonic Manometry, 3D-Transit system
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution Colonic Manometry and 3D-Transit system.Device
Not performed as an intervention, the study is observational.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: All 24 hours of HRCM and 3D-Transit recording
Secondary outcomes (2)
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.
Measured: 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).
Measured: All 24 hours of HRCM and 3D-Transit recording.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start15 Oct 2020 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Sponsor
- Investigators
- Klaus Krogh, MD, ph.d., Study chair, Overall scientific leadership of the protocol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551625
- Sponsor's protocol ID
- HRCM_3DT_DM
- Other IDs
- EUDRAMED: CIV-20-05-032844
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Colonic Motility in Patients With Diabetes Using High Resolution Colonic Manometry and 3D-Transit.
- ClinicalTrials.gov ID
- NCT04551625
- Acronym / sponsor ID
- HRCM_3DT_DM
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetic enteropathy, Neurogastroenterology, Colonic motility, High Resolution Colonic Manometry, 3D-Transit system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients with DM and GI symptoms have reduced high-amplitude, antegrade contractions in the colon when compared to healthy controls (HRCM).
- Patients with DM and GI symptoms have reduced long, fast mass-movements when compared to healthy controls (3D-Transit).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Resolution Colonic Manometry and 3D-Transit system.Not performed as an intervention, the study is observational. | Device | – |
Primary outcome
High amplitude, antegrade contractions assessed with HRCM
Time frame: All 24 hours of HRCM and 3D-Transit recording
Quantity, amplitude and duration of the high amplitude, antegrade propagating contractions accessed with HRCM, when compared to healthy controls.
2 secondary outcomes
Long, fast mass-movements assessed with 3D-Transit
Time frame: All 24 hours of HRCM and 3D-Transit recording.
Distance of capsule movement.
Time frame: All 24 hours of HRCM and 3D-Transit recording.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Krogh, MD, ph.d. study chair
Overall scientific leadership of the protocol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ditte S Iversen, MD (40517858, Dittiver@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High amplitude, antegrade contractions assessed with HRCM (time frame: All 24 hours of HRCM and 3D-Transit recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.