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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group: Immediate G-POEM | Experimental |
| |
| Delayed G-POEM : Standard Treatment Followed by G-POEM at 3 Months | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Level | Glycated hemoglobin (HbA1c) level measured in blood samples | 15 days, 3 months, and 6 months after randomization |
| Time in Hypoglycemia (<70 mg/dL) | Percentage of time spent with glucose values below 70 mg/dL, based on continuous glucose monitoring (CGM) data. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| 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 |
|
| 15 days, 3 months, and 6 months after randomization |
| Time in Hypoglycemia (<54 mg/dL) | Percentage of time spent with glucose values below 54 mg/dL, based on continuous glucose monitoring (CGM) data. | 15 days, 3 months, and 6 months after randomization |
| Time in Hyperglycemia (>180 mg/dL) | Percentage of time spent with glucose values above 180 mg/dL, based on continuous glucose monitoring (CGM) data. | 15 days, 3 months, and 6 months after randomization |
| Time in Hyperglycemia (>250 mg/dL) | Percentage of time spent with glucose values above 250 mg/dL, based on continuous glucose monitoring (CGM) data. | 15 days, 3 months, and 6 months after randomization |
| Mean Glucose Level (mg/dL) | Mean glucose level recorded by CGM over the specified time period. | 15 days, 3 months, and 6 months after randomization |
| Coefficient of Variation (CV) of Glucose (%) | Coefficient of variation of glucose levels measured by CGM. | 15 days, 3 months, and 6 months after randomization |
| Gastric Emptying Assessment | Evaluation of gastric motility via scintigraphy to measure gastric retention at 1h, 2h, and 4h post-standardized meal, performed at each follow-up time point (15 days, 3 months, and 6 months). | 15 days, 3 months, and 6 months |
| Fundic Accommodation Ratio | Calculation of fundic accommodation using the ratio of T0 proximal activity to T0 total activity as per Orthey et al. | 15 days, 3 months, and 6 months |
| Gastroparesis Symptom Severity (GCSI Score) | Gastroparesis symptoms assessed with the Gastroparesis Cardinal Symptom Index (GCSI), a validated questionnaire with a scale ranging from 0 to 5, where higher scores indicate more severe symptoms. | 15 days, 3 months, and 6 months |
| Severity of Upper GI Symptoms (PAGI-SYM Score) | Patient-reported outcome measuring severity of upper GI symptoms using the PAGI-SYM questionnaire, a validated questionnaire with a scale from 0 to 5, where higher scores represent worse symptom severity. | 15 days, 3 months, and 6 months |
| Gastrointestinal Quality of Life (GIQLI Score) | Quality of life related to gastrointestinal symptoms using the validated French version of the GIQLI scale.The total score ranges from 0 to 144, with higher scores indicating better quality of life. | 15 days, 3 months, and 6 months |
| Postprandial abdominal pain (VAS) | Intensity of postprandial abdominal pain assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). | 15 days, 3 months, and 6 months |
| Safety and Adverse Events | Number of participants experiencing serious or unexpected adverse events throughout the follow-up. | From inclusion to the end of the 6-month follow-up, over a total study duration of 36 months |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |