Actively Recruiting
Gastric Pathophysiology in Diabetes
Led by Institute for Clinical and Experimental Medicine · Updated on 2024-05-17
120
Participants Needed
5
Research Sites
247 weeks
Total Duration
On this page
Sponsors
I
Institute for Clinical and Experimental Medicine
Lead Sponsor
P
Poliklinika Agel, Dopravni zdravotnictvi a.s.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gastric Pathophysiology in Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diabetes mellitus type I or II with a minimum disease duration of 3 years
- Specific diabetes treatment (drugs or insulin) for at least 2 years
You will not qualify if you...
- Type II diabetes treated only with diet
- Severe acute uncontrolled diabetes requiring hospitalization
- Treatment with more than one prokinetic agent
- Current or past 12 months treatment with opioids
- Previous major esophageal or gastric surgery
- Organic pyloric or intestinal obstruction
- Severe coagulopathy
- Esophageal or gastric varices or portal gastropathy
- Advanced liver cirrhosis
- Pregnancy or puerperium
- Malignant or pre-malignant gastric diseases, except cured cases
- Rumination syndrome or eating disorders such as anorexia nervosa or bulimia
- Systemic connective tissue disorder
- Inability to give informed consent
- Any condition interfering with study requirements according to the investigator
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Nemocnice AGEL Ostrava-Vítkovice a. s.
Ostrava, Czechia, 703 00
Actively Recruiting
2
University Hospital Ostrava
Ostrava, Czechia, 708 52
Actively Recruiting
3
Institute for Clinical and Experimental Medicine
Prague, Czechia, 14021
Actively Recruiting
4
Military University Hospital Prague
Prague, Czechia, 16902
Actively Recruiting
5
University Hospital Trnava
Trnava, Slovakia, 917 02
Actively Recruiting
Research Team
E
Eva Evinová, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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