Assessing the effects of a surgical procedure on blood sugar control in diabetes patients
Impact of Endoscopic Per-Oral Pyloromyotomy (POP) on Glycemic Control in Gastroparesis Patients With Poorly Controlled Diabetes Mellitus
This study is testing if a surgical procedure can help people with diabetes and stomach issues better control their blood sugar levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04696159 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of per-oral pyloromyotomy (POP) on glycemic control in 40 patients suffering from diabetes and medically refractory gastroparesis. It is a prospective cohort study that will utilize HbA1c values and continuous glucose monitoring (CGM) to measure changes in blood sugar levels before and after the procedure. The researchers hypothesize that patients will experience improved glycemic control and reduced fluctuations in blood glucose levels following POP. The findings aim to inform clinical decisions regarding the timing of endoscopic interventions for patients with uncontrolled diabetes and gastroparesis.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with gastroparesis and an average HbA1c greater than 7.5%.
Not a fit: Patients under 18, those with better glycemic control (HbA1c less than 7.5%), or those unable to comply with study requirements may not benefit.
Why it matters
Potential benefit: If successful, this procedure could significantly improve blood sugar management for patients with diabetes and gastroparesis.
How similar studies have performed: While this approach is innovative, similar studies have shown promising results in improving glycemic control through surgical interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Mathew Allemang, MD — The Cleveland Clinic
- Study coordinator: Deanne Nash, RN
- Email: nashd@ccf.org
- Phone: 216-445-0953
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.