G-POEM for Glycemic Control in Diabetic Gastroparesis

NCT06965543 | Not Yet Recruiting

• 1 other identifier: SFED-166
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastroparesis

Keywords

G-POEM (Gastric Per Oral Endoscopic Myotomy); Gastroparesis; diabetic gastroparesis

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent in target glycemic range >10%

  Proportion of time in the glycemic range 70-180 mg/dL calculated from CGM data over 14 days preceding the 3-month time point

  3 months after randomization

Secondary Outcomes (14)

• HbA1c Level

  15 days, 3 months, and 6 months after randomization

• Time in Hypoglycemia (<70 mg/dL)

  15 days, 3 months, and 6 months after randomization

• Time in Hypoglycemia (<54 mg/dL)

  15 days, 3 months, and 6 months after randomization

• Time in Hyperglycemia (>180 mg/dL)

  15 days, 3 months, and 6 months after randomization

• Time in Hyperglycemia (>250 mg/dL)

  15 days, 3 months, and 6 months after randomization

Study Arms (2)

Experimental Group: Immediate G-POEM

EXPERIMENTAL

Procedure: Immediate G-POEM

Delayed G-POEM : Standard Treatment Followed by G-POEM at 3 Months

ACTIVE COMPARATOR

Procedure: Delayed G-POEM

Interventions

Immediate G-POEM PROCEDURE

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

Experimental Group: Immediate G-POEM

Delayed G-POEM PROCEDURE

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

Delayed G-POEM : Standard Treatment Followed by G-POEM at 3 Months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 90 years;
• Diagnosed with diabetes for at least 5 years and be treated with optimized insulin therapy;
• Severe gastroparesis with gastric retention \>20% at 4h (confirmed by scintigraphy);
• Failure of conventional gastroparesis treatment;
• Continuous glucose monitoring (CGM) in use or willingness to use during study
• Time in range (70-180 mg/dL) \<70%

You may not qualify if:

• Are treated with an automated insulin therapy system (closed-loop);
• Have previously undergone gastric neurostimulation therapy with Enterra (Medtronic ©);
• Have been treated with erythromycin in the past three months;
• Do not provide informed consent;
• Are pregnant or breastfeeding during the study period;
• Are under legal guardianship;
• Have contraindications to the POEM procedure, including contraindications to anesthesia and/or active anticoagulation that cannot be paused;
• Have severe chronic constipation, defined by a Cleveland score \>15 (Agachan et al., Dis Colon Rectum, 1996);
• Have a history of esophagogastric surgery (excluding anti-reflux surgery), including esophagogastric resection or any type of bariatric surgery;
• Have chronic intestinal pseudo-obstruction;
• Have a clinical suspicion of chronic mesenteric ischemia, indicated by severe malnutrition, postprandial pain, and signs of digestive atherosclerosis;
• Refuse to share CGM data via the Libre Link platform;
• Plan or undergo changes in antidiabetic therapy or insulin delivery systems during the study period;
• Are being treated with any gastric-emptying delaying agents, including GLP-1 receptor agonists;
• Are undergoing treatment with ascorbic acid during the study;

Sponsors & Collaborators

• French Society of Digestive Endoscopy: lead

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 11, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 11, 2025

Record last verified: 2025-05