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

Matthew Allemang40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Gastroparesis With Diabetes Mellitus Gastroparesis

Interventions

PyloromyotomyPROCEDURE

Endoscopic Per-Oral Pyloromyotomy (POP)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: Baseline and 6 Month

Secondary Outcomes

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)

Time frame: 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)

Time frame: Baseline and 6 Month

Central Contacts

Deanne Nash, RN

CONTACT

216-445-0953 nashd@ccf.org

Data from ClinicalTrials.gov

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