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.
| Condition(s) | Diabetes Mellitus, Gastroparesis With Diabetes Mellitus, Gastroparesis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study will assess changes in glycemic control in 40 patients with diabetes who undergo per-oral pyloromyotomy (POP) for medically refractory gastroparesis. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Matthew Allemang |
| Locations | Cleveland, Ohio, United States |
| Start date | 2023-01-04 |
| NCT ID | NCT04696159 |
| Official listing | https://clinicaltrials.gov/study/NCT04696159 |