Pathophysiology of Diabetic Gastroparesis

NCT05717205 | Unknown DMC

• 1 other identifier: SJ-980
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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 investigate

• Differences in nervefiber density and morphology
• Cellular and transcriptional changes and indices of glucosemetabolism between groups

Conditions

Gastroparesis Due to Diabetes Mellitus Type I

Keywords

gastroparesis

Outcome Measures

Primary Outcomes (1)

• mucosal nerve length density (MNLD)

  differences in mucosal nerve length density (MNLD) of the gastric fundus and antrum in diabetes patients with and without gastroparesis. MNLD will be assessed by confocal microscopy of mucosal biopsies obtained by oesophago-gastro-duodenoscopy.

  24 months

Secondary Outcomes (9)

• Nerve fibre morphology

  24 months

• Differences in histology

  24 months

• Transcriptional changes

  24 months

• Differences in cell populations

  24 months

• Differences in pyloric distensibility

  24 months

Study Arms (2)

cases with gastroparesis

ACTIVE COMPARATOR

patients with a gastroparesis symptom score index (GCSI) of \> 1.9 will be considered as cases with gastroparesis and will be subjected to technetium-scintigraphy and gastroscopy with tissuesamples from antrum and fundus and bloodsamples of glucosemetabolism

Diagnostic Test: technetium scitigraphy

Controls without gastroparesis

ACTIVE COMPARATOR

patients with a gastroparesis symptom score index (GCSI) of \< 1.9 will be considered as controls without gastroparesis and will be subjected to technetium-scintigraphy and gastroscopy with tissuesamples from antrum and fundus and bloodsamples of glucosemetabolism

Diagnostic Test: technetium scitigraphy

Interventions

technetium scitigraphy DIAGNOSTIC_TEST

patients will have a technetium scintraphy confirming or ruling out gastroparesis. Then the patients will have a gastroscopy with tissue samples from antrum and fundus. During gastroscopy an endo-flip ballon will meassure the distensibility in pylorus.

Also known as: gastroscopy with tissuesamples

Controls without gastroparesis; cases with gastroparesis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes
• age 18-85
• Case group: Gastroparesis verified by technetium scintigraphy and a GCSI score ≥ 1.9
• Control group: Gastroparesis not confirmed by technetium scintigraphy and score GCSI score \< 1.9

You may not qualify if:

• 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 surgery
• Active duodenal/gastric ulcer disease,
• Diseases in the ventricle or previously complicated upper abdominal surgery
• Pregnancy or breast feeding
• Persons who, in the judgement of the investigator, may be unable to follow the protocol.
• Parkinson disease
• metoclopramide 48 hours prior to scintigraphy
• domperidone 48 hours prior to scintigraphy
• macrolide antibiotics 48 hours prior to scintigraphy
• anti-cholinergic agents
• Tricycliv antidepressants
• Glucagon-like peptide-1 analogues
• Lithium
• Diphenhydramine

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Zealand University Hospital: collaborator
• Steno Diabetes Center Copenhagen: collaborator

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Capital Region, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Melina S Hansen, MD

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melina S Hansen, MD

CONTACT

+4528304757; melina.svraka.hansen.01@regionh.dk

John G Karstensen, MD, associate professor

CONTACT

+4540944465; john.gasdal.karstensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: February 8, 2023
• Study Start: February 16, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)