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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Gastroparesis With Diabetes Mellitus, Gastroparesis

Intervention / Treatment
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* Procedure: Pyloromyotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Per-Oral Pyloromyotomy (POP)<br>The study cohort will include 40 patients with a HbA1c >7.5% with medically refractory gastroparesis who are scheduled to undergo POP. Each patient will undergo two 10-day periods of CGM at an interval of approximately seven months, one month prior to the procedure and six months after. Symptoms and diabetes management improvement will be measured by the Gastroparesis Cardinal Symptom Index (GCSI) scores and the Diabetes Self-Management Questionnaire (DSMQ). | Procedure: Pyloromyotomy<br>* Endoscopic Per-Oral Pyloromyotomy (POP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Hemoglobin A1C levels | 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) | Baseline and 6 Month | 
| Change from Baseline in Glucose Levels measured by Continuous Glucose Monitor | 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) | Baseline and 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on Diabetes Self-Management Questionnaire | The Diabetes Self-Management Questionnaire (DSMQ) is a self reported instrument assessing diabetes self-care activities. Possible scores range from 0 (Does not apply) to 3 (Applies to me very much). Change = (Six Month Score - Baseline Score) | Baseline and 6 Month | 
| Change from Baseline on Gastroparesis Cardinal Symptom Index | The Gastroparesis Cardinal Symptom Index (GCSI) is a validated patient-administered questionnaire that is used to assess gastroparesis symptom severity. Possible scores range from 0 (None) to 5 (Very Severe). Change = (Six Month Score - Baseline Score) | Baseline and 6 Month |