Gastric Pathophysiology in Diabetes (DiaFLIP)

Institute for Clinical and Experimental Medicine

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1; Healthy; Functional Dyspepsia; Gastroparesis; Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other

Identifiers

NCT06068114

DiaFLIP

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

120 participants in 2 patient groups

Diabetic patients

Description:

Either type I or type II diabetes mellitus, possibly also suffering from functional dyspepsia or gastroparesis

Healthy controls