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NCT05717205
Pathophysiology of Diabetic Gastroparesis
Conditions: Gastroparesis Due to Diabetes Mellitus Type I
Sex: All
Ages: 18 Years – 85 Years
Phase: NA
Enrollment: 52
Sponsor: Hvidovre University Hospital
Summary
The goal of this study is to explore the pathophysiology of diabetic gastroparesis by conducting an exploratory cohort study.
Participants will be type 1 diabetes patients with and without gastroparesis.
Investigators will investigateDifferences in nervefiber density and morphologyCellular and transcriptional changes and indices of glucosemetabolism between groups
Eligibility Criteria
Inclusion Criteria:Type 1 diabetesage 18-85Case group: Gastroparesis verified by technetium scintigraphy and a GCSI score ≥ 1.9Control group: Gastroparesis not confirmed by technetium scintigraphy and score GCSI score < 1.9Exclusion Criteria:Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study on the discretion of the investigator.Recent gastrointestinal surgeryActive duodenal/gastric ulcer disease,Diseases in the ventricle or previously complicated upper abdominal surgeryPregnancy or breast feedingPersons who, in the judgement of the investigator, may be unable to follow the protocol.Parkinson diseasemetoclopramide 48 hours prior to scintigraphydomperidone 48 hours prior to scintigraphymacrolide antibiotics 48 hours prior to scintigraphyanti-cholinergic agentsTricycliv antidepressantsGlucagon-like peptide-1 analoguesLithiumDiphenhydraminedopamine agonistsprogesterone, L-dopacalcitonineocreotideInterferon alfasucralsulfatebotulinum toxin injections (eg, Botox®) by pyloric injection.
Source: ClinicalTrials.gov (NCT05717205). StuddyBuddy aggregates publicly available trial information.