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Diabetic Gastroparesis Subjects for Gastroparesis

Phase 2 & 3
Waitlist Available
Led By Madhusudan Grover, MBBS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial will test if a new PET scan can detect pro-inflammatory macrophages in the stomach wall of patients with diabetic gastroparesis.

Eligible Conditions
  • Diabetes
  • Gastroparesis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Uptake of 11C-ER 176 in the Stomach Muscle
Secondary outcome measures
Percentage of Immune Cells With CD45 Expression

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Diabetic without gastroparesis subjectsExperimental Treatment1 Intervention
Type I or II diabetes subjects who have not been clinically diagnosed with Gastroparesis. Subjects will receive PET/CT Scan with 11C-ER176
Group II: Diabetic Gastroparesis SubjectsExperimental Treatment2 Interventions
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
Group III: Healthy SubjectsPlacebo Group1 Intervention
Healthy subjects will be age-matched and receive a PET/CT Scan with 11C-ER176
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/CT Scan with 11C-ER176
2021
Completed Phase 3
~20
Core biopsy of gastric muscle
2021
Completed Phase 3
~20

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,071 Total Patients Enrolled
9 Trials studying Gastroparesis
615 Patients Enrolled for Gastroparesis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,174 Total Patients Enrolled
19 Trials studying Gastroparesis
3,407 Patients Enrolled for Gastroparesis
Madhusudan Grover, MBBSPrincipal InvestigatorMayo Clinic
6 Previous Clinical Trials
422 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be a part of this clinical research?

"Up to 12 applicants that suffer from diabetes mellitus and are between 18-70 years old will be accepted. The most important qualifying factor is age, followed by the presence of diabetes mellitus."

Answered by AI

Are people who are over 35 years old being recruited for this clinical trial?

"The age limits for this study are 18-70, as specified in the inclusion criteria."

Answered by AI
~3 spots leftby Apr 2025