NCT04696159

Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes

Impact of Endoscopic Per-Oral Pyloromyotomy (POP) on Glycemic Control in Gastroparesis Patients With Poorly Controlled Diabetes Mellitus

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Matthew Allemang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 medically refractory gastroparesis. The study cohort will consist of 40 patients with poor glycemic control who undergo POP. The investigators propose a prospective cohort study using CGM to compare glycemic profiles before and after POP in patients with diabetic gastroparesis. The investigators hypothesize that patients will have improvement in glycemic control and reduced variation in blood glucose levels (% time in hypo/hyperglycemia) after undergoing POP. These results will aid in clinical decision making, and may indicate an earlier need for endoscopic intervention in patients with uncontrolled diabetes and gastroparesis.

Conditions

• Diabetes Mellitus
• Gastroparesis With Diabetes Mellitus
• Gastroparesis

Interventions

Type	Name	Description
PROCEDURE	Pyloromyotomy	Endoscopic Per-Oral Pyloromyotomy (POP)

Timeline

• Start date: 2023-01-04
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2021-01-06
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States