Trials Sponsors Conditions Drugs Pricing

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
+4 more secondary outcomes

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 scitigraphyDiagnostic 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 gastroparesiscases with gastroparesis

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 1 diabetes
age 18-85

Sponsors & Collaborators

Steno Diabetes Center Copenhagen
Othercollaborator
Hvidovre University Hospital
Otherlead
Zealand University Hospital

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Capital Region, 2650, Denmark

RECRUITING

Melina S Hansen, MDCONTACT+4528304757 melina.svraka.hansen.01@regionh.dk

John G Karstensen, MDCONTACT+4540944465 john.gasdal.karstensen@regionh.dk

MeSH Terms

Conditions

Gastroparesis

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive System

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

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

Actual (reported)

Primary Completion

December 31, 2024

Estimated (date passed)

Pathophysiology of Diabetic Gastroparesis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

cases with gastroparesis

Controls without gastroparesis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

cases with gastroparesis

Controls without gastroparesis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations