Phase 3
N=12
PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis
Diabetes · Gastroparesis With Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT04762719 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Uptake of 11C-ER 176 in the Stomach Muscle — 5.5; 8.4; 4.6; 7.8 SUVmax
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PET/CT Scan with 11C-ER176 (Drug); Core biopsy of gastric muscle (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uptake of 11C-ER 176 in the Stomach Muscle |
5.5; 8.4; 4.6; 7.8; 13.1; 9.0 | — |
| SECONDARY Percentage of Immune Cells With CD45 Expression |
— | — |
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. The researchers are trying 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.
Eligibility Criteria
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.
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
Data sourced from ClinicalTrials.gov (NCT04762719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.