Impact of Endoscopic Per-Oral Pyloromyotomy (POP) on Glycemic Control in Gastroparesis Patients With Poorly Controlled Diabetes Mellitus
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Contact Information
Primary
Deanne Nash, RN
nashd@ccf.org
216-445-0953
Time Frame
Start Date: 2023-01-04
Estimated Completion Date: 2027-06
Participants
Target number of participants: 40
Treatments
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).
Related Therapeutic Areas
Sponsors
Collaborators: Society of American Gastrointestinal and Endoscopic Surgeons
Leads: Matthew Allemang