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.
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mathew Allemang, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- 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)