Gastric Pathophysiology in Diabetes

Launched by INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Gastric Pathophysiology in Diabetes," is studying how diabetes affects the stomach's functions. Researchers want to understand the different ways the stomach works—or doesn't work—in people with diabetes. They will use special devices to measure stomach function in participants and will check these measurements again after a year. The goal is to see how changes in these measurements relate to the overall health of the patients, particularly focusing on those who also experience stomach issues like functional dyspepsia (indigestion) or gastroparesis (slow stomach emptying).

To be eligible for this study, participants need to have either Type 1 or Type 2 diabetes for at least three years and have been on treatment, like medication or insulin, for at least two years. However, those who only manage their diabetes with diet, have severe diabetes complications, or have certain other medical conditions or surgeries are not eligible. If you join, you can expect to have your stomach function measured at the beginning of the study and again after a year, helping researchers learn more about the relationship between diabetes and stomach health.

Gender

ALL

Eligibility 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