十二指腸粘膜表面置換對糖尿病有早期效果


  【24drs.com】研究者報告指出,智利有一篇於39名第二型糖尿病患者進行的首次人類單一組別研究,這些患者進行了內視鏡十二指腸黏膜表面置換-Revita手術(Fractyl),在6個月時有比較好的代謝標記且沒有嚴重持續的副作用。
  
  如果以更大型的對照試驗驗證這些初步成果,醫師們有朝一日將可為糖尿病患提供這個微創治療—似乎可以提供類似於那些進行胃繞道手術者的糖尿病改善結果。
  
  田納西州納什維爾范德比爾特大學醫學暨分子生理學與生物物理學教授Alan D Cherrington博士,在美國糖尿病協會(ADA) 2016年科學研討會發表這些初步研究結果。
  
  根據這篇研究的結果,十二指腸黏膜表面置換是一種研究性的內視鏡手術-熱燒蝕十二指腸黏膜,在4月時獲得歐洲的CE標誌認證;該試驗的這些最新結果則是對代謝標記的效果一探究竟。
  
  迄今,作用機轉依舊未知。Cherrington博士表示,不過,REVITA 1這篇大型的國際追蹤試驗目前正在招納患者,且已經從28名患者蒐集了12週的安全性與效果資料,應有助於提供更多資訊。
  
  他表示,希望更加瞭解為何產生作用,我們可以發展一個相當簡單的方法來做到這一點。他提醒,目前,這個手術有希望,但未獲證明。
  
  會議主席、紐約州布朗克斯區亞伯愛因斯坦醫學院Meredith A Hawkins醫師發表評論時表示,當然,數據是驚人的;醫師們或許不敢去想胃手術對患者的影響,所以,一個較無侵犯性的手術且能有如此巨大之影響的概念,是相當有趣的。
  
  此外,研究者也對於進一步的研究是否可揭櫫機轉,以及探究這個手術是否改變了腸道荷爾蒙或微生物或其他一些因素感到興趣。
  
  Cherrington博士解釋,還不清楚熱燒蝕一段十二指腸黏膜表面如何導致血糖標記的改善,但是,這或許與十二指腸黏膜在術後與營養物質的接觸面積減少有關,如同在胃繞道手術者所見。
  
  他指出,這項研究有一部分是受到巴氏食道症(Barrett's esophagus)患者之異常食道組織進行的BARRX燒蝕手術之啟發,原始研究是在豬隻進行。
  
  這篇首次的人類單一組別研究共納入44名第二型糖尿病患者,其中39人進行了手術。要符合資格,患者的HbA1c必須是7.5% -12%,且正在服用一種或多種降血糖藥。
  
  患者的平均年齡為53歲,約三分之二(64%)是男性,平均而言,他們的身體質量指數(BMI)是30.8、HbA1c是9.6%;患有糖尿病的時間平均為5.7年。
  
  約三分之一(11人)患者進行了短段(3.4公分)十二指腸燒蝕,其他28名患者進行長段(9.3公分)十二指腸燒蝕,手術時間為1小時,在麻醉下由1名胃腸科醫師進行。
  
  術後,患者進行低熱量飲食2週,從液態飲食轉變成泥狀飲食。
  
  手術耐受情況良好;在追蹤的6個月間,患者少有不良反應,且皆可經由治療解決。
  
  6個月時,平均HbA1c比開始時降低1.2%(P < .001),進行長段十二指腸燒蝕之患者的HbA1c降幅較大。
  
  即使糖尿病藥物的使用減少,一定範圍內的開始時HbA1c都有發生HbA1c降低且明顯。
  
  Cherrington博士總結指出,雖然還需要後續研究探討十二指腸黏膜表面置換的效果、安全性與臨床運用,這次的研究顯示出這個新的內視鏡十二指腸手術直接治療第二型糖尿病的效果。
  
  資料來源: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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