NCT04696159NARecruiting

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

Matthew Allemang

Start Date

1/4/2023

Completion Date

6/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Patients 18 years of age and older 2. Patients with gastroparesis with an average HbA1c\> 7.5% over the past 3 months 3. 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. 4. Patients are able to complete all study requirements Exclusion Criteria: 1. Patients \<18 years of age 2. Patients with gastroparesis with an average HbA1c\< 7.5% over the past 3 months 3. Patients unable or refuse to complete the study requirements 4. Patients who are unable or refuse to wear a CGM sensor 5. Patients with insulin pumps 6. Patients who already use a CGM

Interventions

PROCEDURE

Pyloromyotomy

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Conditions

Diabetes MellitusGastroparesis With Diabetes MellitusGastroparesis

Locations

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States