PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    12
  • sponsor
    Mayo Clinic
Updated on 21 July 2021

Summary

Macrophage-driven immune dysregulation has been shown to be involved in pathophysiology of diabetic gastroparesis. Currently, there are no non-invasive ways to study macrophage activation in humans. This study aims to determine the utility of 11C-ER176 based PET-CT scanning to determine pro-inflammatory macrophage activation in gastric wall of patients with diabetic gastroparesis.

Details
Condition Diabetes Mellitus, diabetes mellitus (dm), type 2 diabetes mellitus, NIDDM, Diabetes Mellitus, Type 2, Diabetic Gastroparesis, Diabetes, type 2 diabetes, noninsulin-dependent diabetes mellitus, Diabetes Mellitus Type 2, diabetes type 2, Diabetes (Pediatric), Diabetes Mellitus Types I and II, type ii diabetes, Diabetes Prevention
Treatment PET/CT Scan with 11C-ER176, Core biopsy of gastric muscle
Clinical Study IdentifierNCT04762719
SponsorMayo Clinic
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: 18 to 70 years of age
Ability to provide informed consent
Type I or II diabetes mellitus
Gastroparesis defined by gastric retention of Tc-99m > 60 % at 2 hrs and/or > 10% at 4 hours on scintigraphy
Average Gastroparesis Cardinal Symptom Index (GCSI) 3 indicating moderate-severe symptoms

Exclusion Criteria

Women who are pregnant or cannot stop breast feeding for 24 hours
Using anti-coagulants, anti-inflammatory medications (NSAIDs, corticosteroids, etc.) or immunosuppressive therapies within the 4 weeks prior
Opioid use within the last 4 weeks of gastric emptying scintigraphy
Prior gastric surgery
History of IBD, celiac disease, eosinophilic gastroenteritis, microscopic colitis
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