Studying Stomach Function in People With Diabetes and Stomach Symptoms
Observes stomach function in adults with diabetes, repeated after one year.
Plain-language title generated from the registry record
Registry title: Gastric Pathophysiology in Diabetes
Key facts
- Where
- Trnava, SlovakiaSee the site
Could this be for you?
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?
Source: NCT06068114, who can take part
Where in Slovakia
- University Hospital TrnavaTrnava, SlovakiaTaking people
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?
Trial details
- Who runs it
- Institute for Clinical and Experimental Medicine
- Trial code
- NCT06068114
- Record updated
- 17 May 2024
- Original description
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
Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus
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.
Inclusion: Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years.
Exclusion: 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.