Actively Recruiting
Detailed Assessment of Gastric Functions in Patients With Diabetes Mellitus
Led by Institute for Clinical and Experimental Medicine · Updated on 2024-05-17
120
Participants Needed
5
Research Sites
N/A
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
Researchers are conducting a detailed study to assess various stomach functions in people with diabetes mellitus, including those who may also experience functional dyspepsia or gastroparesis. The goal is to understand how the stomach's muscles and movements change in diabetes and how these changes relate to overall health. The study will monitor differences in gastric function over time to better understand the disease. Participants include adults with type 1 or type 2 diabetes who have been managing their condition for several years. Healthy controls are also included for comparison. The study involves measuring stomach function using several devices and tests at the start and repeating these measurements after one year to observe any changes. Participants will undergo assessments such as pyloric muscle distensibility measurements, gastric emptying tests by scintigraphy and breath test, electrogastrography, and autonomic function testing. Symptom scores related to gastric function will be collected at baseline, six months, and twelve months. The study will monitor the relationships between these measures and overall patient health throughout the 12-month period.
CONDITIONS
Brief Title
Gastric Pathophysiology in Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Diagnosis of type 1 or type 2 diabetes mellitus
- Diabetes duration of at least 3 years
- Diabetes treatment with drugs or insulin for at least 2 years
You will not qualify if you...
- Type 2 diabetes treated with diet only
- Severe uncontrolled diabetes requiring hospitalization
- Treatment with more than one prokinetic agent
- Active or recent opioid treatment within 12 months
- Previous major esophageal or gastric surgery
- Organic pyloric or intestinal obstruction
- Severe blood clotting disorders
- Presence of esophageal or gastric varices or portal gastropathy
- Advanced liver cirrhosis
- Pregnancy or postpartum period
- Malignant or pre-malignant gastric diseases unless cured
- Rumination syndrome or eating disorders
- Systemic connective tissue disorders
- Unable to give informed consent
- Any condition interfering with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and 12 months
Participants undergo assessments of gastric functions including pyloric distensibility, gastric emptying tests, electrogastrography, and autonomic function testing.
2 visits (in-person)
Duration - 12 months with assessments at baseline, 6, and 12 months
Participants are monitored through symptom questionnaires to assess gastric symptoms and quality of life over the course of the study.
3 visits (in-person)
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
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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