G-POEM for Glycemic Control in Diabetic Gastroparesis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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

Первичные конечные точки

• Percentage of time spent in target glycemic range >10% [Срок оценки: 3 months after randomization]

Вторичные конечные точки (12)

• HbA1c Level [Срок оценки: 15 days, 3 months, and 6 months after randomization]
• Time in Hypoglycemia (<70 mg/dL) [Срок оценки: 15 days, 3 months, and 6 months after randomization]
• Time in Hypoglycemia (<54 mg/dL) [Срок оценки: 15 days, 3 months, and 6 months after randomization]
• Time in Hyperglycemia (>180 mg/dL) [Срок оценки: 15 days, 3 months, and 6 months after randomization]
• Time in Hyperglycemia (>250 mg/dL) [Срок оценки: 15 days, 3 months, and 6 months after randomization]
• Mean Glucose Level (mg/dL) [Срок оценки: 15 days, 3 months, and 6 months after randomization]
• Coefficient of Variation (CV) of Glucose (%) [Срок оценки: 15 days, 3 months, and 6 months after randomization]
• Gastric Emptying Assessment [Срок оценки: 15 days, 3 months, and 6 months]
• Fundic Accommodation Ratio [Срок оценки: 15 days, 3 months, and 6 months]
• Gastroparesis Symptom Severity (GCSI Score) [Срок оценки: 15 days, 3 months, and 6 months]
• Severity of Upper GI Symptoms (PAGI-SYM Score) [Срок оценки: 15 days, 3 months, and 6 months]
• Gastrointestinal Quality of Life (GIQLI Score) [Срок оценки: 15 days, 3 months, and 6 months]

Критерии участия

Критерии включения

• 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%

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06965543 · SFED-166

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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