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This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).
This is a prospective, single-armed, feasibility study enrolling individuals with a recent diagnosis of type 2 diabetes. Participants will be followed for 6 months for the primary endpoint and 2 years in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic duodenal recellularization via electroporation therapy (pulsENDO) | Experimental | pulsENDO procedure entails the ablation of the duodenal mucosa with irreversible electroporation (IRE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsENDO treatment | Procedure | The pulsENDO procedure utilizes the pulsENDO catheter to deliver non-thermal pulsed electric field to the duodenum to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum under endoscopic visualisation, starting from D4 and repeated proximally. Approximately 10-18 cm of axial length of the duodenum is treated. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c ≤6.5% without glucose lowering drugs | Proportion of participants with HbA1c ≤6.5% without glucose lowering drugs | 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change in HbA1c (%) from baseline to Month 24 | 24 months post-procedure |
| Total body weight loss (%TBWL) | Percent total body weight loss (%TBWL) from baseline to Month 24 |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Ng, FRCSEd(Gen) | Contact | +85235052956 | stephenng@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Ng, FRCSEd(Gen) | Prince of Wales Hospital, the Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese University of Hong Kong | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| 24 months post-procedure |
| Incidence of adverse events | Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) | within 30 days post-procedure |
| Body fat percentage | Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24 | 24 months post-procedure |
| Change in Quality of Life | measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 24 | 24 months post-procedure |
| Hepatic steatosis index | level from baseline to Month 24 | 24 months post-procedure |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |