Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-27 @ 5:09 AM
Study NCT ID:
NCT04696159
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2020-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
Sponsor:
Matthew Allemang
Organization:
Study Overview
Official Title:
Impact of Endoscopic Per-Oral Pyloromyotomy (POP) on Glycemic Control in Gastroparesis Patients With Poorly Controlled Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: