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

This study is looking at how a procedure called Per-Oral Pyloromyotomy (POP) affects blood sugar control in people with diabetes and gastroparesis. Gastroparesis is a condition where your stomach empties food too slowly. Researchers want to see if POP can improve your Hemoglobin A1C (a measure of average blood sugar over 2-3 months) and daily blood sugar levels. You might be able to join if you are 18 or older, have gastroparesis with an average HbA1c over 7.5% in the last three months, and have a confirmed diagnosis of gastroparesis. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study that will enroll 40 participants. It is a prospective cohort study, meaning participants will be followed forward in time.
What's involved
You would have your Hemoglobin A1C and glucose levels measured at the start of the study and again at 6 months. You would also undergo the Endoscopic Per-Oral Pyloromyotomy (POP) procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the procedure, with measurements taken at baseline and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04696159

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

Active, Not Recruiting
NAAges 18+InterventionalSupportive care
Matthew Allemang
~40 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Pyloromyotomy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Hemoglobin A1C levels
Measured over Baseline and 6 Month
+1 more outcome measured
Diabetes Mellitus
Gastroparesis With Diabetes Mellitus
Gastroparesis
1 sites across 1 states
Ohio1
  • Mathew Allemang, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Change from Baseline in Hemoglobin A1C levelsBaseline and 6 Month

    Glycemic control will be evaluated by measuring change in Hemoglobin A1C (HbA1c) levels. Poor glycemic control defined as an average HbA1c \> 7.5%. Change = (Six Month Score - Baseline Score)

  • Change from Baseline in Glucose Levels measured by Continuous Glucose MonitorBaseline and 6 Month

    Glycemic control will be evaluated by measuring average glucose levels using Continuous Glucose Monitors (CGM). Normal glucose levels 74-99 mg/dL. Change = (Six Month Score - Baseline Score)