Assessing gastric functions in patients with diabetes
Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus
This study looks at how diabetes affects stomach function in people with Type 1 and Type 2 diabetes to see if there are any problems and how these issues relate to their overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 5 sites (Ostrava and 4 other locations) |
| Trial ID | NCT06068114 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the pathophysiology of gastric functions in patients with diabetes mellitus, including both Type 1 and Type 2 diabetes. The researchers will utilize various measurement devices to evaluate gastric functions and identify any malfunctions. After an initial assessment, follow-up measurements will be conducted after one year to observe changes and their correlation with the patients' overall health. The study specifically aims to explore the relationship between gastric function and conditions such as functional dyspepsia and gastroparesis in diabetic patients.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Type 1 or Type 2 diabetes for at least three years, who have been on specific treatment for a minimum of two years.
Not a fit: Patients with Type 2 diabetes managed solely through diet or those with severe complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of gastric complications in diabetes, leading to improved management strategies for affected patients.
How similar studies have performed: While similar studies have explored gastric function in diabetes, this specific approach focusing on comprehensive pathophysiological assessment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (diabetic group): * Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years Exclusion Criteria (diabetic group): * Diabetes mellitus type II being treated with a diet only * Severe acute decompensation of diabetes (uncontrolled diabetes) necessitating hospitalization * 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) * Organic pyloric (or intestinal) obstruction (fibrotic stricture, etc.) * Severe coagulopathy * Esophageal or gastric varices and /or portal gastropathy * Advanced liver cirrhosis * Pregnancy or puerperium * 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 * Inability to obtain informed consent * Any other condition, which in the opinion of the investigator would interfere with study requirements
Where this trial is running
Ostrava and 4 other locations
- Nemocnice AGEL Ostrava-Vítkovice a. s. — Ostrava, Czechia (Recruiting)
- University Hospital Ostrava — Ostrava, Czechia (Recruiting)
- Institute for Clinical and Experimental Medicine — Prague, Czechia (Recruiting)
- Military University Hospital Prague — Prague, Czechia (Recruiting)
- University Hospital Trnava — Trnava, Slovakia (Recruiting)
Study contacts
- Study coordinator: Eva Evinová, MD
- Email: eva.evinova@vtn.agel.cz
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.