Assessing gastric functions in patients with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Eversense Gemini system with new flash glucose feature — testing accuracy and safety

  This will test whether the Eversense Gemini wearable glucose monitor with a new flash feature gives accurate and safe glucose readings for adults with type 1 or type 2 diabetes.

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• Evaluating LY4057996 in Healthy Individuals and Those with Type 1 and Type 2 Diabetes

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• Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients

  This study tests whether using Body Surface Gastric Mapping can help predict which medications will help people with gastroparesis or functional dyspepsia see improvement.

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• Comparing single-session and multiple-session laser treatment for diabetic eye disease

  This study is testing whether one session or multiple sessions of laser treatment works better for people with newly diagnosed diabetic eye disease to help them keep their vision and avoid complications.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.