NCT06965543

G-POEM for Glycemic Control in Diabetic Gastroparesis

Randomized Controlled Clinical Trial Evaluating the Effect of Endoscopic Pyloromyotomy Via Gastric POEM on Glycemic Control in Patients With Diabetes and Gastroparesis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: French Society of Digestive Endoscopy · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Gastroparesis, commonly caused by diabetes, affects 30-50% of diabetic individuals and complicates glycemic control due to its bidirectional relationship with blood glucose levels. Current treatments are often ineffective. G-POEM, a minimally invasive endoscopic technique, has demonstrated promising results in improving digestive symptoms, particularly in diabetic patients, with over 80% success. However, its impact on glycemic control has not yet been investigated, highlighting the need for further research.

Detailed description

Gastroparesis is a condition characterized by delayed gastric emptying, resulting in various digestive symptoms. Diabetes is the leading global cause of gastroparesis. This complication affects approximately 30-50% of individuals with diabetes, typically appearing after many years of disease progression and frequently in the presence of other vascular complications. It is associated with autonomic neuropathy and hyperglycemia. The bidirectional relationship between gastric emptying and blood glucose levels contributes to the complexity of diabetes management, increasing the risk of both postprandial hypoglycemia and delayed hyperglycemia. Existing treatments, including prokinetic and antiemetic medications, are often poorly tolerated and of limited efficacy. G-POEM (Gastric Per Oral Endoscopic Myotomy) is an endoscopic technique designed to treat refractory gastroparesis by targeting pyloric muscle hypertonicity. This procedure has demonstrated favorable outcomes in approximately two-thirds of cases and presents a favorable safety profile. The diabetic population appears to benefit most from this intervention, with over 80% reporting symptom improvement. To date, no study has evaluated the impact of G-POEM on glycemic parameters in patients with diabetic gastroparesis. This clinical trial aims to address this knowledge gap.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
PROCEDURE	Immediate G-POEM	Gastric POEM (G-POEM) performed under general anesthesia. A submucosal tunnel will be created along the greater curvature of the stomach to access the pyloric muscle under endoscopic vision. The pylorus will be incised at two locations with a dual myotomy between the 5 and 8 o'clock positions on the clock face
PROCEDURE	Delayed G-POEM	Participants will receive standard medical treatment, including prokinetic agents, antiemetics (ondansetron 8 mg twice daily), nutritional support, and dietary counseling. Laxative treatments will be prescribed as needed. After three months, participants will undergo G-POEM as described above

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2025-05-11
• Last updated: 2025-05-11