Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
Impact of Endoscopic Per-Oral Pyloromyotomy (POP) on Glycemic Control in Gastroparesis Patients With Poorly Controlled Diabetes Mellitus
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Jan 2023
Longer than P75 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedStudy Start
First participant enrolled
January 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
July 24, 2025
July 1, 2025
3.4 years
August 14, 2020
July 21, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Change from Baseline on Diabetes Self-Management Questionnaire
Baseline and 6 Month
Change from Baseline on Gastroparesis Cardinal Symptom Index
Baseline and 6 Month
Study Arms (1)
Endoscopic Per-Oral Pyloromyotomy (POP)
EXPERIMENTALThe 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).
Interventions
Endoscopic Per-Oral Pyloromyotomy (POP)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Related Publications (6)
Jung HK, Choung RS, Locke GR 3rd, Schleck CD, Zinsmeister AR, Szarka LA, Mullan B, Talley NJ. The incidence, prevalence, and outcomes of patients with gastroparesis in Olmsted County, Minnesota, from 1996 to 2006. Gastroenterology. 2009 Apr;136(4):1225-33. doi: 10.1053/j.gastro.2008.12.047. Epub 2008 Dec 24.
PMID: 19249393BACKGROUNDRodriguez J, Strong AT, Haskins IN, Landreneau JP, Allemang MT, El-Hayek K, Villamere J, Tu C, Cline MS, Kroh M, Ponsky JL. Per-oral Pyloromyotomy (POP) for Medically Refractory Gastroparesis: Short Term Results From the First 100 Patients at a High Volume Center. Ann Surg. 2018 Sep;268(3):421-430. doi: 10.1097/SLA.0000000000002927.
PMID: 30004920BACKGROUNDRamzan Z, Duffy F, Gomez J, Fisher RS, Parkman HP. Continuous glucose monitoring in gastroparesis. Dig Dis Sci. 2011 Sep;56(9):2646-55. doi: 10.1007/s10620-011-1810-z. Epub 2011 Jul 7.
PMID: 21735078BACKGROUNDTanenberg RJ, Pfeifer MA. Continuous glucose monitoring system: a new approach to the diagnosis of diabetic gastroparesis. Diabetes Technol Ther. 2000;2 Suppl 1:S73-80. doi: 10.1089/15209150050214168. No abstract available.
PMID: 11469637BACKGROUNDBailey TS, Chang A, Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol. 2015 Mar;9(2):209-14. doi: 10.1177/1932296814559746. Epub 2014 Nov 3.
PMID: 25370149BACKGROUNDRole of Continuous Glucose Monitoring in Diabetes Treatment. Arlington (VA): American Diabetes Association; 2018 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK538971/
PMID: 30958664BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathew Allemang, MD
The Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 14, 2020
First Posted
January 6, 2021
Study Start
January 4, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
July 24, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share