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

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ClinicalTrials.gov Identifier: NCT04696159
Recruitment Status : Not yet recruiting
First Posted : January 6, 2021
Last Update Posted : March 11, 2022
Sponsor:
Collaborator:
Society of American Gastrointestinal and Endoscopic Surgeons
Information provided by (Responsible Party):
Matthew Allemang, The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Gastroparesis With Diabetes Mellitus Gastroparesis Procedure: Pyloromyotomy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Endoscopic Per-Oral Pyloromyotomy (POP) on Glycemic Control in Gastroparesis Patients With Poorly Controlled Diabetes Mellitus
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Endoscopic Per-Oral Pyloromyotomy (POP)
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
Endoscopic Per-Oral Pyloromyotomy (POP)


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1C levels [ Time Frame: Baseline and 6 Month ]
    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)

  2. Change from Baseline in Glucose Levels measured by Continuous Glucose Monitor [ Time Frame: Baseline and 6 Month ]
    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)


Secondary Outcome Measures :
  1. Change from Baseline on Diabetes Self-Management Questionnaire [ Time Frame: Baseline and 6 Month ]
    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)

  2. Change from Baseline on Gastroparesis Cardinal Symptom Index [ Time Frame: Baseline and 6 Month ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04696159


Contacts
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Contact: Michael Klingler, MD 216-970-4618 klinglm@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Contact: Mathew Allemang, MD    216-491-7861    ALLEMAM@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Society of American Gastrointestinal and Endoscopic Surgeons
Investigators
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Principal Investigator: Mathew Allemang, MD The Cleveland Clinic
More Information
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Additional Information:

Publications:

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Responsible Party: Matthew Allemang, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04696159    
Other Study ID Numbers: 19-1460
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gastroparesis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations