Status:
NOT_YET_RECRUITING
G-POEM for Glycemic Control in Diabetic Gastroparesis
Lead Sponsor:
French Society of Digestive Endoscopy
Conditions:
Gastroparesis
Eligibility:
All Genders
18-90 years
Phase:
NA
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 ...
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 approx...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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;
- Have not previously attempted therapy with at least one prokinetic drug;
- Are actively treated with opioids;
- Have had prior pyloromyotomy or pyloroplasty;
- Have known eosinophilic gastroenteritis;
- Have an organic obstruction of the pylorus or intestinal tract (e.g., fibrotic stenosis);
- Have a severe coagulopathy;
- Have esophageal or gastric varices and/or portal hypertension gastropathy;
- Have decompensated liver cirrhosis (Child B or Child C);
- Have an active gastroduodenal ulcer;
- Have active cancer or precancerous conditions of the stomach or duodenum (dysplasia, gastric cancer, GIST).
- Have a known medical condition that, in the investigator's opinion, could interfere with the study protocol;
- Have experienced diabetic ketoacidosis requiring hospitalization within six months prior to enrollment;
- Have had a severe hypoglycemic episode requiring hospitalization within six months prior to enrollment.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06965543
Start Date
July 1 2025
End Date
July 1 2028
Last Update
May 11 2025
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