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The effects of laparoscopic Roux-en-Y gastric bypass and one-anastomosis gastric bypass on glycemic control and remission of type 2 diabetes mellitus: study protocol for a multi-center randomized controlled trial (the DIABAR-trial).

التفاصيل البيبلوغرافية
العنوان: The effects of laparoscopic Roux-en-Y gastric bypass and one-anastomosis gastric bypass on glycemic control and remission of type 2 diabetes mellitus: study protocol for a multi-center randomized controlled trial (the DIABAR-trial).
المؤلفون: van Rijswijk A; Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands., van Olst N; Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands.; Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands., Meijnikman AS; Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.; Department of Internal Medicine, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands., Acherman YIZ; Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands., Bruin SC; Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands., van de Laar AW; Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands., van Olden CC; Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands., Aydin O; Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.; Department of Internal Medicine, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands., Borger H; Department of Internal Medicine, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands., Beuers UHW; Department of Gastroenterology and Hepatology and Tytgat Institute for Liver and Intestinal Research, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands., Herrema H; Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands., Verheij J; Department of Pathology, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands., Apers JA; Department of Surgery, Franciscus Gasthuis, Kleiweg 500, 3045 PM, Rotterdam, the Netherlands., Bäckhed F; Wallenberg Laboratory, Department of Molecular and Clinical Medicine, University of Gothenburg, SE-413 45, Gothenburg, Sweden.; Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Blegdamsvej 3B, Building 7, DK-2200, Copenhagen, Denmark., Gerdes VEA; Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.; Department of Internal Medicine, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands.; Department of Internal Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands., Nieuwdorp M; Department of Vascular Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.; Wallenberg Laboratory, Department of Molecular and Clinical Medicine, University of Gothenburg, SE-413 45, Gothenburg, Sweden.; Department of Internal Medicine, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.; Institute for Cardiovascular research, Amsterdam UMC, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands., de Brauw LM; Department of Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, the Netherlands. mdebrauw@spaarnegasthuis.nl.
المصدر: Trials [Trials] 2022 Oct 22; Vol. 23 (1), pp. 900. Date of Electronic Publication: 2022 Oct 22.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Diabetes Mellitus, Type 2*/complications , Diabetes Mellitus, Type 2*/surgery , Gastric Bypass*/adverse effects , Gastric Bypass*/methods , Obesity, Morbid*/surgery, Humans ; Bile Acids and Salts ; Blood Glucose/metabolism ; Glycemic Control ; Laparoscopy ; Multicenter Studies as Topic ; Quality of Life ; Randomized Controlled Trials as Topic ; Treatment Outcome
مستخلص: Background: Metabolic surgery induces rapid remission of type 2 diabetes mellitus (T2DM). There is a paucity of high level evidence comparing the efficacy of the laparoscopic Roux-en-Y gastric bypass (RYGB) and the laparoscopic one-anastomosis gastric bypass (OAGB) in glycemic control. Also, the mechanisms that drive the conversion of T2DM in severe obese subjects to euglycemia are poorly understood.
Methods: The DIABAR-trial is an open, multi-center, randomized controlled clinical trial with 10 years follow-up which will be performed in 220 severely obese patients, diagnosed with T2DM and treated with glucose-lowering agents. Patients will be randomized in a 1:1 ratio to undergo RYGB or OAGB. The primary outcome is glycemic control at 12 months follow-up. Secondary outcome measures are diverse and include weight loss, surgical complications, psychologic status and quality of life, dietary behavior, gastrointestinal symptoms, repetitive bloodwork to identify changes over time, glucose tolerance and insulin sensitivity as measured by mixed meal tests, remission of T2DM, presence of non-alcoholic fatty liver disease/non-alcoholic steatohepatitis in liver biopsy, oral and fecal microbiome, cardiovascular performance, composition of bile acids, and the tendency to develop gallstones.
Discussion: The DIABAR-trial is one of the few randomized controlled trials primarily aimed to evaluate the glycemic response after the RYGB and OAGB in severe obese patients diagnosed with T2DM. Secondary aims of the trial are to contribute to a deeper understanding of the mechanisms that drive the remission of T2DM in severe obese patients by identification of microbial, immunological, and metabolic markers for metabolic response and to compare complications and side effects of RYGB and OAGB.
Trial Registration: ClinicalTrials.gov NCT03330756 ; date first registered: October 13, 2017.
(© 2022. The Author(s).)
References: Surg Obes Relat Dis. 2018 Apr;14(4):509-515. (PMID: 29555031)
N Engl J Med. 2017 Feb 16;376(7):641-651. (PMID: 28199805)
Obes Surg. 2014 Sep;24(9):1430-5. (PMID: 24682767)
J Am Coll Surg. 2011 Mar;212(3):301-9. (PMID: 21247780)
BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884)
J Clin Endocrinol Metab. 2021 Mar 8;106(3):750-761. (PMID: 33248441)
Ann Surg. 2005 Jul;242(1):20-8. (PMID: 15973097)
Ann Surg. 2013 Oct;258(4):628-36; discussion 636-7. (PMID: 24018646)
Curr Obes Rep. 2018 Jun;7(2):139-146. (PMID: 29637413)
J Visc Surg. 2016 Aug;153(4):321. (PMID: 27349519)
Surg Endosc. 2019 Feb;33(2):401-410. (PMID: 29943058)
JAMA. 2014 Jun 11;311(22):2297-304. (PMID: 24915261)
Obes Surg. 2014 Jul;24(7):1044-51. (PMID: 24566662)
Diabetes. 2005 Nov;54(11):3265-73. (PMID: 16249454)
Surg Obes Relat Dis. 2019 Dec;15(12):2038-2044. (PMID: 31734066)
Br J Surg. 2015 Apr;102(5):451-60. (PMID: 25708572)
Obes Surg. 2001 Jun;11(3):276-80. (PMID: 11433900)
J Visc Surg. 2010 Oct;147(5 Suppl):e31-7. (PMID: 20920907)
Br J Surg. 1995 Feb;82(2):216-22. (PMID: 7749697)
Obes Surg. 2015 Aug;25(8):1417-24. (PMID: 25511752)
Obes Surg. 2014 Oct;24(10):1749-56. (PMID: 25056233)
Lancet. 2021 May 15;397(10287):1830-1841. (PMID: 33965067)
Lancet. 2021 Jan 23;397(10271):293-304. (PMID: 33485454)
Ann Surg. 2004 Jan;239(1):1-11. (PMID: 14685093)
J Visc Surg. 2016 Jun;153(3):231-2. (PMID: 26926431)
Obes Surg. 2005 May;15(5):648-54. (PMID: 15946455)
Obes Surg. 2008 Sep;18(9):1130-3. (PMID: 18566866)
Nutrients. 2019 Apr 01;11(4):. (PMID: 30939855)
Endocr Rev. 2018 Apr 1;39(2):133-153. (PMID: 29309555)
Diabetes Care. 2016 Jun;39(6):861-77. (PMID: 27222544)
Obes Surg. 2001 Dec;11(6):773-7. (PMID: 11775581)
Surg Endosc. 2014 Jan;28(1):156-63. (PMID: 23982648)
J Laparoendosc Adv Surg Tech A. 2003 Aug;13(4):229-39. (PMID: 14561251)
Clin Obes. 2018 Jun;8(3):159-169. (PMID: 29573175)
Surg Obes Relat Dis. 2012 Nov-Dec;8(6):671-7. (PMID: 23058451)
JAMA. 2013 Dec 11;310(22):2416-25. (PMID: 24189773)
Obes Surg. 2012 May;22(5):697-703. (PMID: 22411569)
Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. (PMID: 7677463)
Updates Surg. 2011 Dec;63(4):239-42. (PMID: 22105765)
Ann Surg. 2014 Dec;260(6):1040-7. (PMID: 24374541)
J Intern Med. 2021 Mar;289(3):340-354. (PMID: 32640105)
N Engl J Med. 2004 Dec 23;351(26):2683-93. (PMID: 15616203)
Obes Surg. 2019 Sep;29(9):3047-3053. (PMID: 31290104)
Diabetes. 2007 Jul;56(7):1761-72. (PMID: 17456850)
Surg Obes Relat Dis. 2016 Feb;12(2):297-303. (PMID: 26826920)
Diabetologia. 2018 Feb;61(2):257-264. (PMID: 29224190)
Diabetes Care. 2018 Jan;41(Suppl 1):S13-S27. (PMID: 29222373)
Surg Obes Relat Dis. 2015 Jan-Feb;11(1):137-41. (PMID: 25701959)
Obes Surg. 2005 Oct;15(9):1304-8. (PMID: 16259892)
Am J Med. 2009 Mar;122(3):248-256.e5. (PMID: 19272486)
Obes Surg. 2005 Mar;15(3):398-404. (PMID: 15826476)
Diabetes Care. 2016 Jun;39(6):893-901. (PMID: 27222547)
Lancet. 2019 Mar 30;393(10178):1299-1309. (PMID: 30851879)
N Engl J Med. 2009 Jul 30;361(5):445-54. (PMID: 19641201)
J Am Coll Surg. 2012 Jun;214(6):892-900. (PMID: 22521443)
Ann Surg. 2011 Oct;254(4):633-40. (PMID: 21897200)
N Engl J Med. 2017 Sep 21;377(12):1143-1155. (PMID: 28930514)
فهرسة مساهمة: Keywords: Metabolic outcome; One-anastomosis gastric bypass; Randomized controlled trial; Roux-en-Y gastric bypass; Type 2 diabetes mellitus
سلسلة جزيئية: ClinicalTrials.gov NCT03330756
المشرفين على المادة: 0 (Bile Acids and Salts)
0 (Blood Glucose)
تواريخ الأحداث: Date Created: 20221023 Date Completed: 20221027 Latest Revision: 20221027
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC9588204
DOI: 10.1186/s13063-022-06762-3
PMID: 36273149
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-022-06762-3