Status:
RECRUITING
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
Lead Sponsor:
Matthew Allemang
Collaborating Sponsors:
Society of American Gastrointestinal and Endoscopic Surgeons
Conditions:
Diabetes Mellitus
Gastroparesis With Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.
Detailed Description
This will be a prospective study using HbA1c values and continuous glucose monitoring (CGM) to assess changes in glycemic control in patients with diabetes who undergo per-oral pyloromyotomy (POP) for...
Eligibility Criteria
Inclusion
- Patients 18 years of age and older
- Patients with gastroparesis with an average HbA1c\> 7.5% over the past 3 months
- Patient that have a diagnosis of gastroparesis established by documented delayed gastric emptying by either a wireless motility capsule study or a nuclear gastric emptying study, with no evidence of gastric obstruction.
- Patients are able to complete all study requirements
Exclusion
- Patients \<18 years of age
- Patients with gastroparesis with an average HbA1c\< 7.5% over the past 3 months
- Patients unable or refuse to complete the study requirements
- Patients who are unable or refuse to wear a CGM sensor
- Patients with insulin pumps
- Patients who already use a CGM
Key Trial Info
Start Date :
January 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04696159
Start Date
January 4 2023
End Date
June 1 2027
Last Update
July 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195