PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

Mayo Clinic

Status and phase

Completed

Phase 3

Phase 2

Conditions

Diabetes

Gastroparesis With Diabetes Mellitus

Treatments

Diagnostic Test: Core biopsy of gastric muscle

Drug: PET/CT Scan with 11C-ER176

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04762719

20-010260

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 3 patient groups, including a placebo group

Diabetic Gastroparesis Subjects

Experimental group

Description:

Type I or II diabetes subjects who also have a diagnosis of Gastroparesis (defined by gastric retention of Tc-99m \>20% at 4 hrs on scintigraphy). Subjects will receive PET/CT Scan with 11C-ER176 and a core biopsy of gastric muscle

Treatment:

Diagnostic Test: Core biopsy of gastric muscle

Drug: PET/CT Scan with 11C-ER176

Diabetic without gastroparesis subjects

Experimental group

Description:

Type I or II diabetes subjects who have not been clinically diagnosed with Gastroparesis. Subjects will receive PET/CT Scan with 11C-ER176

Treatment:

Drug: PET/CT Scan with 11C-ER176

Healthy Subjects

Placebo Comparator group

Description: