A Study to Evaluate Dynamic Positron Emission Tomography Imaging to Explain Macrophage Activation in Diabetic Gastroparesis

Overview

About this study

The purpose of this study is to demonstrate feasibility of dynamic 11C-ER176 PET imaging to identify macrophage-driven immune dysregulation in gastric muscle of patients with DG. Non-invasive quantitative assessment with PET can significantly add to our diagnostic armamentarium for patients with diabetic gastroenteropathy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Madhusudan Grover, M.B.B.S.

Open for enrollment

Contact information:

Margaret Breen-Lyles

(507) 293-0237

Breen-Lyles.Margaret@mayo.edu

More information

Publications

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Study Results Summary

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Supplemental Study Information

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