Celine B.E. Busch MD , Kim van den Hoek MD , Annieke C.G. van Baar MD, PhD , Suzanne Meiring MD, PhD , Thomas A. Bouwmeester MD, PhD , Frits Holleman MD, PhD , Max Nieuwdorp MD, PhD , Jacques J.G.H.M. Bergman MD, PhD
{"title":"2型糖尿病患者十二指肠再细胞化后经电穿孔治疗联合胰高血糖素样肽-1受体激动剂的持久胰岛素消除","authors":"Celine B.E. Busch MD , Kim van den Hoek MD , Annieke C.G. van Baar MD, PhD , Suzanne Meiring MD, PhD , Thomas A. Bouwmeester MD, PhD , Frits Holleman MD, PhD , Max Nieuwdorp MD, PhD , Jacques J.G.H.M. Bergman MD, PhD","doi":"10.1016/j.igie.2025.03.012","DOIUrl":null,"url":null,"abstract":"<div><h3>Background and Aims</h3><div>Re-cellularization via electroporation therapy (ReCET) is an endoscopic procedure that uses electroporation to induce cellular apoptosis and subsequent re-epithelization in the duodenum. ReCET has demonstrated a positive effect on glycaemia. In this study, a single ReCET procedure was combined with a glucagon-like peptide-1 receptor agonist (GLP-1RA) with the goal of eliminating insulin treatment in patients with type 2 diabetes (T2D). At 12 months 86% of patients remained off insulin. Here we report the longer-term efficacy and safety of ReCET combined with GLP-1RA over 24 months.</div></div><div><h3>Methods</h3><div>This was a first-in-human study in patients with T2D on basal insulin (28-75 years of age; body mass index, 24-40 kg/m<sup>2</sup>; hemoglobin A<sub>1c</sub> [HbA<sub>1c</sub>], ≤64 mmol/mol; C-peptide, ≥0.2 nmol/L). All of the patients underwent ReCET, after which insulin was discontinued and semaglutide (GLP-1RA) was initiated. The follow-up was extended to 24 months for initial responders (off insulin and HbA<sub>1c</sub> ≤58 mmol/mol at 12 months). Primary end points were number of responders (efficacy) and number of adverse events, serious adverse events, and hypoglycemic events (safety). Secondary end points included glycemic, metabolic, and cardiovascular parameters, and treatment satisfaction scores.</div></div><div><h3>Results</h3><div>Fourteen patients underwent endoscopic ReCET. Eleven initial responders completed the 24-month follow-up, of which 1 withdrew consent after 18 months. All patients remained off insulin with adequate glycemic control. No procedure-related serious adverse events or severe hypoglycemic events were observed during 24 months of follow-up. Homeostatic model assessment of insulin resistance and liver fat percentage improved significantly compared with baseline.</div></div><div><h3>Conclusions</h3><div>These results suggest that duodenal ReCET combined with semaglutide is durable, allowing insulin elimination up to 24 months, and appears safe. Glycemic control was maintained, and metabolic health improved during the 24-month follow-up period.</div></div>","PeriodicalId":100652,"journal":{"name":"iGIE","volume":"4 2","pages":"Pages 120-128.e1"},"PeriodicalIF":0.0000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Durable insulin elimination after duodenal re-cellularization via electroporation therapy combined with glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes\",\"authors\":\"Celine B.E. Busch MD , Kim van den Hoek MD , Annieke C.G. van Baar MD, PhD , Suzanne Meiring MD, PhD , Thomas A. Bouwmeester MD, PhD , Frits Holleman MD, PhD , Max Nieuwdorp MD, PhD , Jacques J.G.H.M. Bergman MD, PhD\",\"doi\":\"10.1016/j.igie.2025.03.012\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background and Aims</h3><div>Re-cellularization via electroporation therapy (ReCET) is an endoscopic procedure that uses electroporation to induce cellular apoptosis and subsequent re-epithelization in the duodenum. ReCET has demonstrated a positive effect on glycaemia. In this study, a single ReCET procedure was combined with a glucagon-like peptide-1 receptor agonist (GLP-1RA) with the goal of eliminating insulin treatment in patients with type 2 diabetes (T2D). At 12 months 86% of patients remained off insulin. Here we report the longer-term efficacy and safety of ReCET combined with GLP-1RA over 24 months.</div></div><div><h3>Methods</h3><div>This was a first-in-human study in patients with T2D on basal insulin (28-75 years of age; body mass index, 24-40 kg/m<sup>2</sup>; hemoglobin A<sub>1c</sub> [HbA<sub>1c</sub>], ≤64 mmol/mol; C-peptide, ≥0.2 nmol/L). All of the patients underwent ReCET, after which insulin was discontinued and semaglutide (GLP-1RA) was initiated. The follow-up was extended to 24 months for initial responders (off insulin and HbA<sub>1c</sub> ≤58 mmol/mol at 12 months). Primary end points were number of responders (efficacy) and number of adverse events, serious adverse events, and hypoglycemic events (safety). Secondary end points included glycemic, metabolic, and cardiovascular parameters, and treatment satisfaction scores.</div></div><div><h3>Results</h3><div>Fourteen patients underwent endoscopic ReCET. Eleven initial responders completed the 24-month follow-up, of which 1 withdrew consent after 18 months. All patients remained off insulin with adequate glycemic control. No procedure-related serious adverse events or severe hypoglycemic events were observed during 24 months of follow-up. Homeostatic model assessment of insulin resistance and liver fat percentage improved significantly compared with baseline.</div></div><div><h3>Conclusions</h3><div>These results suggest that duodenal ReCET combined with semaglutide is durable, allowing insulin elimination up to 24 months, and appears safe. Glycemic control was maintained, and metabolic health improved during the 24-month follow-up period.</div></div>\",\"PeriodicalId\":100652,\"journal\":{\"name\":\"iGIE\",\"volume\":\"4 2\",\"pages\":\"Pages 120-128.e1\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"iGIE\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2949708625000391\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"iGIE","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2949708625000391","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Durable insulin elimination after duodenal re-cellularization via electroporation therapy combined with glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes
Background and Aims
Re-cellularization via electroporation therapy (ReCET) is an endoscopic procedure that uses electroporation to induce cellular apoptosis and subsequent re-epithelization in the duodenum. ReCET has demonstrated a positive effect on glycaemia. In this study, a single ReCET procedure was combined with a glucagon-like peptide-1 receptor agonist (GLP-1RA) with the goal of eliminating insulin treatment in patients with type 2 diabetes (T2D). At 12 months 86% of patients remained off insulin. Here we report the longer-term efficacy and safety of ReCET combined with GLP-1RA over 24 months.
Methods
This was a first-in-human study in patients with T2D on basal insulin (28-75 years of age; body mass index, 24-40 kg/m2; hemoglobin A1c [HbA1c], ≤64 mmol/mol; C-peptide, ≥0.2 nmol/L). All of the patients underwent ReCET, after which insulin was discontinued and semaglutide (GLP-1RA) was initiated. The follow-up was extended to 24 months for initial responders (off insulin and HbA1c ≤58 mmol/mol at 12 months). Primary end points were number of responders (efficacy) and number of adverse events, serious adverse events, and hypoglycemic events (safety). Secondary end points included glycemic, metabolic, and cardiovascular parameters, and treatment satisfaction scores.
Results
Fourteen patients underwent endoscopic ReCET. Eleven initial responders completed the 24-month follow-up, of which 1 withdrew consent after 18 months. All patients remained off insulin with adequate glycemic control. No procedure-related serious adverse events or severe hypoglycemic events were observed during 24 months of follow-up. Homeostatic model assessment of insulin resistance and liver fat percentage improved significantly compared with baseline.
Conclusions
These results suggest that duodenal ReCET combined with semaglutide is durable, allowing insulin elimination up to 24 months, and appears safe. Glycemic control was maintained, and metabolic health improved during the 24-month follow-up period.
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