{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"Research Square"}],"indexed":{"date-parts":[[2022,4,4]],"date-time":"2022-04-04T22:31:21Z","timestamp":1649111481406},"posted":{"date-parts":[[2021,1,21]]},"group-title":"In Review","reference-count":0,"publisher":"Research Square Platform LLC","license":[{"start":{"date-parts":[[2021,1,21]],"date-time":"2021-01-21T00:00:00Z","timestamp":1611187200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2021,1,19]]},"abstract":"<jats:title>Abstract<\/jats:title>\n        <jats:p><jats:bold>Background:<\/jats:bold> Roux-en-Y gastric bypass (RYGB) surgery is one of the most efficient procedures for the treatment of obesity, also improving metabolic and inflammatory status, in patients with mild obesity. The underlying mechanisms have not been fully understood, but gut microbiota is hypothesized to play a key role. Our aim was to evaluate the association between gut microbiota changes and anthropometric, metabolic and inflammatory profiles after metabolic surgery compared with medical therapy, in type 2 diabetic (T2DM) adults with mild obesity (BMI 30-35 Kg\/m<jats:sup>2<\/jats:sup>).<jats:bold>Methods:<\/jats:bold> DM<jats:sup>2<\/jats:sup> was an open-label, randomised controlled clinical trial (RCT: ISRCTN53984585) with 2 arms: (i) surgical, and (ii) medical. The main outcome was gut microbiota changes after: metabolic surgery (Roux-en-Y gastric bypass - RYGB) <jats:italic>versus<\/jats:italic> standard medical therapy. Secondary outcomes included anthropometric, metabolic and inflammatory profiles. Clinical visits, blood workup, and stool samples were collected at baseline and months (M)1, 3, 6, 12. Gut microbiota was profiled using 16S rRNA targeted sequencing.<jats:bold>Results:<\/jats:bold> Twenty patients were included: 10 in surgical and 10 in medical arm. Anthropometric and metabolic comparative analysis favoured RYGB over medical arm. At M12, the percentage of weight loss was 25.5% <jats:italic>vs<\/jats:italic>. 4.9% (p&lt;0.001) and HbA1c was 6.2% <jats:italic>vs<\/jats:italic>. 7.7% (p&lt;0.001) respectively.We observed a continuous increase of genus richness after RYGB up until M12. In the medical arm, genus richness ended-up being significantly lower at M12. Composition analysis indicated significant changes of the overall microbial ecosystem (permanova p=0.004, [R<jats:sup>2<\/jats:sup>=0.17]) during the follow-up period after RYGB. There was a strong association between improvement of anthropometric\/metabolic\/inflammatory biomarkers and increase in microbial richness and Proteobacterial lineages.<jats:bold>Conclusions:<\/jats:bold> This was the first RCT studying composite clinical, analytic, and microbiome changes in T2DM patients with class 1 obesity after RYGB <jats:italic>versus<\/jats:italic> standard medical therapy. The remarkable phenotypic improvement after surgery occurred concomitantly with changes in the gut microbiome, but at a lower level.<jats:bold>Trial registration: <\/jats:bold>ISRCTN53984585 (http:\/\/www.isrctn.com\/ISRCTN53984585)<\/jats:p>","DOI":"10.21203\/rs.3.rs-150935\/v1","type":"posted-content","created":{"date-parts":[[2021,1,21]],"date-time":"2021-01-21T23:44:35Z","timestamp":1611272675000},"source":"Crossref","is-referenced-by-count":0,"title":["Gut Microbiota Changes After Metabolic Surgery in Adult Diabetic Patients With Mild Obesity: a Randomised Controlled Trial"],"prefix":"10.21203","author":[{"given":"Eva","family":"Lau","sequence":"first","affiliation":[{"name":"Centro Hospitalar Universitario S\u00e3o Jo\u00e3o"}]},{"given":"Eugeni","family":"Belda","sequence":"additional","affiliation":[{"name":"Institute of Cardiometabolism and Nutrition: Institut de Cardiometabolisme et Nutrition"}]},{"given":"Paul","family":"Picq","sequence":"additional","affiliation":[{"name":"Institute of Cardiometabolism and Nutrition: Institut de Cardiometabolisme et Nutrition"}]},{"given":"Davide","family":"Carvalho","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Universit\u00e1rio de S\u00e3o Jo\u00e3o: Centro Hospitalar Universitario de Sao Joao"}]},{"given":"Manuel","family":"Ferreira-Magalh\u00e3es","sequence":"additional","affiliation":[{"name":"CINTESIS"}]},{"given":"Maria Manuel","family":"Silva","sequence":"additional","affiliation":[{"name":"Centro Hospitalar de S\u00e3o Jo\u00e3o EPE: Centro Hospitalar Universitario de Sao Joao"}]},{"given":"Isaac","family":"Barroso","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Universit\u00e1rio de S\u00e3o Jo\u00e3o: Centro Hospitalar Universitario de Sao Joao"}]},{"given":"Flora","family":"Correia","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Universit\u00e1rio de S\u00e3o Jo\u00e3o: Centro Hospitalar Universitario de Sao Joao"}]},{"given":"Cidalia Pina","family":"Vaz","sequence":"additional","affiliation":[{"name":"Centro Hospitalar de S\u00e3o Jo\u00e3o: Centro Hospitalar Universitario de Sao Joao"}]},{"given":"Isabel","family":"Miranda","sequence":"additional","affiliation":[{"name":"University of Porto Faculty of Medicine: Universidade do Porto Faculdade de Medicina"}]},{"given":"Adelino","family":"Barbosa","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Universit\u00e1rio de S\u00e3o Jo\u00e3o: Centro Hospitalar Universitario de Sao Joao"}]},{"given":"Karine","family":"Klement","sequence":"additional","affiliation":[{"name":"ICAN Nutriomics: Institut de Cardiometabolisme et Nutrition Nutriomics"}]},{"given":"Joel","family":"Dore","sequence":"additional","affiliation":[{"name":"MetaGenoPolis"}]},{"given":"Paula","family":"Freitas","sequence":"additional","affiliation":[{"name":"Sao Joao Hospital: Centro Hospitalar Universitario de Sao Joao"}]},{"given":"Edi","family":"Prifti","sequence":"additional","affiliation":[{"name":"Institute of Cardiometabolism and Nutrition: Institut de Cardiometabolisme et Nutrition"}]}],"member":"8761","container-title":[],"original-title":[],"link":[{"URL":"https:\/\/www.researchsquare.com\/article\/rs-150935\/v1","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.researchsquare.com\/article\/rs-150935\/v1.html","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,3,17]],"date-time":"2021-03-17T17:31:02Z","timestamp":1616002262000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchsquare.com\/article\/rs-150935\/v1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,21]]},"references-count":0,"URL":"https:\/\/doi.org\/10.21203\/rs.3.rs-150935\/v1","relation":{},"subject":[],"published":{"date-parts":[[2021,1,21]]},"subtype":"preprint"}}