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

Matthew Allemang

Status: Enrolling

Conditions: Gastroparesis; Diabetes Mellitus; Gastroparesis With Diabetes Mellitus

Treatments: Procedure: Pyloromyotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04696159

19-1460

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Endoscopic Per-Oral Pyloromyotomy (POP)

Experimental group

Description:

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).

Treatment:

Procedure: Pyloromyotomy