RecruitingNot ApplicableNCT04696159

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

Sponsor

Matthew Allemang

Enrollment

40 participants

Start Date

Jan 4, 2023

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Gastroparesis Gastroparesis With Diabetes Mellitus

Summary

This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria6

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

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Interventions

PROCEDUREPyloromyotomy

Endoscopic Per-Oral Pyloromyotomy (POP)

Locations(1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

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NCT04696159

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