Studying Stomach Function in People With Diabetes and Stomach Symptoms
Observes stomach function in adults with diabetes, repeated after one year.
Key facts
- Who runs it
- Institute for Clinical and Experimental Medicine
- Where
- Ostrava and Prague, CzechiaSee the 4 sitesAlso in 1 other country, 1 site
- Trial code
- Registry title
- Gastric Pathophysiology in Diabetes
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 5 Oct 2022
- Expected to end
- 30 Jun 2027
- Type of study
- Observational, 2 groups
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 with type 1 or type 2 diabetes who have had it for at least 3 years. The record also lists healthy volunteers.
- Age
- 18 to 70 years
- Sex
- All
- Disease stage
- Type 1 or type 2 diabetes for at least 3 years, with at least 2 years of drug or insulin treatment.
- Earlier treatment
- Must have had diabetes drugs or insulin for at least 2 years. Cannot have had opioid treatment in the 12 months before enrolment.
Main reasons for not taking part
- Type 2 diabetes treated with diet only
- Severe diabetes crisis that needs hospital care
- Previous major stomach or food pipe surgery
- Pregnancy or the weeks after birth
- Advanced liver cirrhosis
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years
Who cannot take part
- 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)
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in Czechia
Also in 1 other country, 1 site
- Nemocnice AGEL Ostrava - Vitkovice a.s.Ostrava, CzechiaContact: Eva Evinová, MDTaking people
- University Hospital OstravaOstrava, CzechiaContact: Marek Buzga, PhDTaking people
- Institute for Clinical and Experimental MedicinePrague, CzechiaContact: Dagmar Šimková, MDTaking people
- Military University Hospital PraguePrague, CzechiaContact: Jan Bures, prof.Taking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Diabetic patients
Either type I or type II diabetes mellitus, possibly also suffering from functional dyspepsia or gastroparesis
- Healthy controls
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus
- Plain-language title
- Studying Stomach Function in People With Diabetes and Stomach SymptomsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06068114, who can take part
- Record updated
- 12 November 2026