Status:
COMPLETED
PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis
Lead Sponsor:
Mayo Clinic
Conditions:
Diabetes
Gastroparesis With Diabetes Mellitus
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
PHASE3
Brief 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. T...
Eligibility Criteria
Inclusion
- 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
- 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.
- Healthy Subjects Exclusion criteria
- no clinical history of diabetes or any GI symptoms
- no inflammatory disorders of the GI tract
- no use of anti-inflammatory or immunosuppressive therapies
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04762719
Start Date
May 10 2021
End Date
March 31 2022
Last Update
April 18 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905