NCT06068114Recruiting
Gastric Pathophysiology in Diabetes
Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 17 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a comprehensive pathophysiological study assessing various gastric functions in patients with diabetes mellitus. The investigators aim to examine the stomach with various measurement devices to gain information about its different functions and malfunctions. After the initial measurements, the examinations will be repeated after a year in each patient. Changes in the measurement values will be examined and their relations to each other and to the overall health of the patients will be investigated. For example it is hypothesised that diabetic patients also suffering from functional dyspepsia or gastroparesis will also show some changes in the function of the pyloric muscle.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 26 Sept 2023
- Start date
- 5 Oct 2022
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06068114
What you commit to
- Study type: Observational
- Planned participants: 120
- From 5 Oct 2022 to the primary completion date, 30 Jun 2027
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diabetes mellitus type II being treated with a diet only
- Concomitant treatment with more than one prokinetic agent
- Active treatment with opioids or a history of treatment with opioids within 12 months before enrolment
- Previous esophageal or major gastric surgery (e.g. esophageal myotomy, esophagectomy, antireflux surgery, Billroth I or II gastric resection, gastric pull-through, pyloromyotomy, pyloroplasty, gastric electrical stimulation)
Other illness
- Severe acute decompensation of diabetes (uncontrolled diabetes) necessitating hospitalization
- Malignant or pre-malignant gastric diseases (dysplasia, gastric cancer, GIST): patients with a history of such disease after its cure are eligible for enrolment
- The presence of a rumination syndrome or eating disorders (anorexia nervosa, bulimia). In case of doubts, a psychiatric examination will be performed.
- Systemic connective tissue disorder
- Any other condition, which in the opinion of the investigator would interfere with study requirements
Other
- Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.)
- Severe coagulopathy
- Esophageal or gastric varices and /or portal gastropathy
- Advanced liver cirrhosis
- Pregnancy or puerperium
- Inability to obtain informed consent
Who the study is looking for
- Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nemocnice AGEL Ostrava - Vitkovice a.s. Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| University Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Military University Hospital Prague Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Institute for Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| University Hospital Trnava Coordinator of this site? Confirm its status | Trnava | Slovakia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.