Gastric Pathophysiology in Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-05

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ultrasound Evaluation of Gastric Emptying in Diabetic Patients

NCT03187145

Diabetes

UNKNOWN

The Effects of Z-338 in Subjects With and Without Functional Dyspepsia

NCT00298194

Dyspepsia

COMPLETED PHASE2

Symptoms and Endoscopic Results in Consideration of Pretreatment

NCT00612404

Gastrointestinal Diseases

COMPLETED

To Study the EGG Abnormalities in Healthy Subjects and in Patients With Idiopathic and Diabetic Gastroparesis.

NCT05624034

Gastroparesis Diabetes Complications Idiopathic Gastric Motility Disorder +1 more

UNKNOWN

Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms

NCT01316484

Diabetes Mellitus Gastroparesis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Functional Dyspepsia Gastroparesis Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diabetic patients

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

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diabetes mellitus type I or II, minimal duration of the disease 3 years, minimal duration of specific treatment (drugs, insulin) 2 years

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes