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NCT Number: NCT04696159

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

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

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Key information

Conditions

Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Gastroparesis Gastroparesis With Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Mathew Allemang, MD

CONTACT

[email protected]

216 491-7861

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pyloromyotomy

Procedure

Endoscopic Per-Oral Pyloromyotomy (POP)

Primary outcomes

  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 outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Deanne Nash, RN

CONTACT

[email protected]

216-445-0953

Sponsors and collaborators

Lead sponsor

Matthew Allemang

Other

Collaborators

  • Society of American Gastrointestinal and Endoscopic Surgeons

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2021
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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