G-POEM for Glycemic Control in Diabetic Gastroparesis

Sponsor
French Society of Digestive Endoscopy
Study ID
NCT06965543
Status
Not Yet Recruiting

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Conditions

  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

First listed
May 11, 2025
Start date
Jul 31, 2025
Status verified
May 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group: Immediate G-POEM
  • Active Comparator: Delayed G-POEM : Standard Treatment Followed by G-POEM at 3 Months

Primary Outcome Measure

Percentage of time spent in target glycemic range >10% [ Time Frame: 3 months after randomization ]

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