十二指肠粘膜表面置换对糖尿病有早期效果


  【24drs.com】研究者报告指出,智利有一篇于39名第二型糖尿病患者进行的首次人类单一组别研究,这些患者进行了内视镜十二指肠黏膜表面置换-Revita手术(Fractyl),在6个月时有比较好的代谢标记且没有严重持续的副作用。
  
  如果以更大型的对照试验验证这些初步成果,医师们有朝一日将可为糖尿病患提供这个微创治疗—似乎可以提供类似于那些进行胃绕道手术者的糖尿病改善结果。
  
  田纳西州纳什维尔范德比尔特大学医学暨分子生理学与生物物理学教授Alan D Cherrington博士,在美国糖尿病协会(ADA) 2016年科学研讨会发表这些初步研究结果。
  
  根据这篇研究的结果,十二指肠黏膜表面置换是一种研究性的内视镜手术-热烧蚀十二指肠黏膜,在4月时获得欧洲的CE标志认证;该试验的这些最新结果则是对代谢标记的效果一探究竟。
  
  迄今,作用机转依旧未知。Cherrington博士表示,不过,REVITA 1这篇大型的国际追踪试验目前正在招纳患者,且已经从28名患者搜集了12周的安全性与效果资料,应有助于提供更多信息。
  
  他表示,希望更加了解为何产生作用,我们可以发展一个相当简单的方法来做到这一点。他提醒,目前,这个手术有希望,但未获证明。
  
  会议主席、纽约州布朗克斯区亚伯爱因斯坦医学院Meredith A Hawkins医师发表评论时表示,当然,数据是惊人的;医师们或许不敢去想胃手术对患者的影响,所以,一个较无侵犯性的手术且能有如此巨大之影响的概念,是相当有趣的。
  
  此外,研究者也对于进一步的研究是否可揭櫫机转,以及探究这个手术是否改变了肠道荷尔蒙或微生物或其它一些因素感到兴趣。
  
  Cherrington博士解释,还不清楚热烧蚀一段十二指肠黏膜表面如何导致血糖标记的改善,但是,这或许与十二指肠黏膜在术后与营养物质的接触面积减少有关,如同在胃绕道手术者所见。
  
  他指出,这项研究有一部分是受到巴氏食道症(Barrett's esophagus)患者之异常食道组织进行的BARRX烧蚀手术之启发,原始研究是在猪只进行。
  
  这篇首次的人类单一组别研究共纳入44名第二型糖尿病患者,其中39人进行了手术。要符合资格,患者的HbA1c必须是7.5% -12%,且正在服用一种或多种降血糖药。
  
  患者的平均年龄为53岁,约三分之二(64%)是男性,平均而言,他们的身体质量指数(BMI)是30.8、HbA1c是9.6%;患有糖尿病的时间平均为5.7年。
  
  约三分之一(11人)患者进行了短段(3.4公分)十二指肠烧蚀,其它28名患者进行长段(9.3公分)十二指肠烧蚀,手术时间为1小时,在麻醉下由1名胃肠科医师进行。
  
  术后,患者进行低热量饮食2周,从液态饮食转变成泥状饮食。
  
  手术耐受情况良好;在追踪的6个月间,患者少有不良反应,且皆可经由治疗解决。
  
  6个月时,平均HbA1c比开始时降低1.2%(P < .001),进行长段十二指肠烧蚀之患者的HbA1c降幅较大。
  
  即使糖尿病药物的使用减少,一定范围内的开始时HbA1c都有发生HbA1c降低且明显。
  
  Cherrington博士总结指出,虽然还需要后续研究探讨十二指肠黏膜表面置换的效果、安全性与临床运用,这次的研究显示出这个新的内视镜十二指肠手术直接治疗第二型糖尿病的效果。
  
  资料来源:http://www.24drs.com/
  
  Native link:Duodenal Mucosal Resurfacing Shows Early Promise in Diabetes

Duodenal Mucosal Resurfacing Shows Early Promise in Diabetes

By Marlene Busko
Medscape Medical News

NEW ORLEANS — In a first-in-human, single-arm study, 39 patients in Chile with type 2 diabetes who underwent endoscopic duodenal mucosal resurfacing, known as the Revita procedure (Fractyl), had better levels of metabolic markers at 6 months with no serious lasting adverse effects, researchers report.

If these promising early findings are reproduced in further, larger studies with a sham control arm, clinicians may someday be able to offer diabetic patients this minimally invasive treatment — which seems to provide potential improvements in diabetes similar to those seen with gastric-bypass surgery.

Alan D Cherrington, PhD, professor of medicine and molecular physiology and biophysics at Vanderbilt University, Nashville, Tennessee, presented these preliminary findings here at the American Diabetes Association (ADA) 2016 Scientific Sessions,

Duodenal mucosal resurfacing is an investigational endoscopic procedure that thermally ablates duodenal mucosa, and it received the CE Mark in Europe in April, based on the results of this study; these latest data from the trial take a closer look at the effect on metabolic markers.

To date, the mechanism of action remains unknown. However, a large international follow-up trial, REVITA 1, which is currently enrolling patients and has already collected 12-week safety and efficacy data on 28 patients, should help provide more information, said Dr Cherrington.

"The hope is that by learning more about why this works, we can develop a fairly simple approach to do this," he told Medscape Medical News. At the moment, the procedure is "promising but by no means proven," he cautioned.

"Certainly the data are striking," session chair Meredith A Hawkins, MD, from Albert Einstein College of Medicine, the Bronx, NY, commented to Medscape Medical News.

Clinicians may "shudder to think of the impact of gastric surgery on patients, so the concept of a much less invasive procedure that would be able to have such dramatic effects…is very intriguing," she said.

"Moreover, it will be interesting to see whether further research can shed light on the mechanism and see whether the procedure alters gut hormones or the microbiome or some other factors."

Better Levels of Metabolic Markers at 6 Months

It is not clear how thermal ablation of a section of the duodenal mucosal surface leads to improved levels of glycemic markers, but this may be related to reduced nutrient contact with duodenal mucosa after this procedure, as seen after gastric-bypass surgery, Dr Cherrington explained.

This line of research was partly inspired by the BARRX ablation procedure of abnormal esophageal tissue in patients who have Barrett's esophagus, he added. The original research was done in a pig model.

This first-in-human study enrolled 44 patients with type 2 diabetes at the same center, and 39 patients underwent the procedure. To be eligible, patients had to have an HbA1c of 7.5% to 12% while taking one or more antidiabetic agents.

The patients had a mean age of 53, and about two-thirds (64%) were male. On average, they had a body mass index (BMI) of 30.8 and an HbA1c of 9.6%; they had had diabetes for an average of 5.7 years.

About a third (11) of the patients had a short, 3.4-cm section of the duodenum ablated, and the other 28 patients had a longer, 9.3-cm section of the duodenum ablated, in a 1-hour procedure performed under anesthesia by a gastroenterologist.

After the procedure, the patients were put on a low-calorie diet for 2 weeks and transitioned from consuming liquids to pureed foods.

The procedure was well tolerated; patients had few adverse events during 6 months of follow-up, which all resolved with treatment.

At 6 months, the average HbA1c was reduced by 1.2% from baseline (P < .001). The reductions in HbA1c were greater in the patients who had received an ablation of a longer section of the duodenum.

The HbA1c reductions occurred across a range of baseline HbA1c and were evident despite reduced use of diabetes medications.

"While further examination of duodenal mucosa resurfacing efficacy, safety, and clinical utility is needed, this study demonstrates the promise of this novel, endoscopic, duodenum-directed treatment of type 2 diabetes," Dr Cherrington summarized.

The trial was sponsored by Fractyl. Cherrington is on advisory panels for Biocon, Fractyl, Merck, Metavention, NuSirt Biopharma, Sensulin, and Zafgen. He is a consultant for Eli Lilly, Silver Lake, Islet Sciences, Novo Nordisk, Profil Institute for Clinical Research, Thermalin Diabetes, Thetis Pharmaceuticals, vTv Therapeutics, ViaCyte, and Viking. He receives research support from Eli Lilly, Merck, Metavention, Novo Nordisk, Silver Lake, and Thermalin Diabetes and holds shares for Fractyl, Metavention, Sensulin, Thetis Pharmaceuticals, and Zafgen. Disclosures for the coauthors are listed in the abstract.

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American Diabetes Association 2016 Scientific Sessions; June 10, 2016; New Orleans, Louisiana.

    
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