Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity: A Randomized Clinical Trial.

Autor:	Cohen RV; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Pereira TV; Applied Health Research Center, St Michael's Hospital, Toronto, Ontario, Canada.; Health Technology Assessment Unit, International Research Center, Oswaldo Cruz German Hospital, São Paulo, Brazil., Aboud CM; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Petry TBZ; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Lopes Correa JL; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Schiavon CA; Research Institute, Hospital do Coração, São Paulo, Brazil., Pompílio CE; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Pechy FNQ; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., da Costa Silva ACC; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., de Melo FLG; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Cunha da Silveira LP; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., de Paris Caravatto PP; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Halpern H; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Monteiro FLJ; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., da Costa Martins B; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Kuga R; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Palumbo TMS; The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil., Docherty NG; Diabetes Complications Research Center, UCD Conway Institute, University College Dublin School of Medicine, Dublin, Ireland.; Institute of Clinical Sciences, Sahlgrenska University Hospital, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden., le Roux CW; Diabetes Complications Research Center, UCD Conway Institute, University College Dublin School of Medicine, Dublin, Ireland.; Investigative Medicine, Imperial College London, London, United Kingdom.
Jazyk:	angličtina
Zdroj:	JAMA surgery [JAMA Surg] 2020 Aug 01; Vol. 155 (8), pp. e200420. Date of Electronic Publication: 2020 Aug 19.
DOI:	10.1001/jamasurg.2020.0420
Abstrakt:	Importance: Early-stage chronic kidney disease (CKD) characterized by microalbuminuria is associated with future cardiovascular events, progression toward end-stage renal disease, and early mortality in patients with type 2 diabetes. Objective: To compare the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) surgery vs best medical treatment in patients with early-stage CKD, type 2 diabetes, and obesity. Design, Setting, and Participants: For this randomized clinical trial, patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up. Intervention: A total of 100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 [calculated as weight in kilograms divided by height in meters squared]), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min) were randomized 1:1 to receive best medical treatment (n = 49) or RYGB (n = 51). Main Outcomes and Measures: The primary outcome was remission of albuminuria (uACR <30 mg/g). Secondary outcomes were CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety. Results: A total of 100 patients (mean [SD] age, 51.4 [7.6] years; 55 [55%] male) were randomized: 51 to RYGB and 49 to best medical care. Remission of albuminuria occurred in 55% of patients (95% CI, 39%-70%) after best medical treatment and 82% of patients (95% CI, 72%-93%) after RYGB (P = .006), resulting in CKD remission rates of 48% (95% CI, 32%-64%) after best medical treatment and 82% (95% CI, 72%-92%) after RYGB (P = .002). The geometric mean uACRs were 55% lower after RYGB (10.7 mg/g of creatinine) than after best medical treatment (23.6 mg/g of creatinine) (P < .001). No difference in the rate of serious adverse events was observed. Conclusions and Relevance: After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity. Trial Registration: ClinicalTrials.gov Identifier: NCT01821508.
Databáze:	MEDLINE
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