title: Microvascular Outcomes after Metabolic Surgery (MOMS) in patients with type 2 diabetes mellitus and class I obesity: rationale and design for a randomised controlled trial.
abstract: There are several randomised controlled trials (RCTs) that have already shown that metabolic/bariatric surgery achieves short-term and long-term glycaemic control while there are no level 1A of evidence data regarding the effects of surgery on the microvascular complications of type 2 diabetes mellitus (T2DM).
  
  
  
  The aim of this trial is to investigate the long-term efficacy and safety of the Roux-en-Y gastric bypass (RYGB) plus the best medical treatment (BMT) versus the BMT alone to improve microvascular outcomes in patients with T2DM with a body mass index (BMI) of 30-34.9 kg/m2.
  
  
  
  This study design includes a unicentric randomised unblinded controlled trial. 100 patients (BMI from 30 to 34.9 kg/m2) will be randomly allocated to receive either RYGB plus BMT or BMT alone. The primary outcome is the change in the urine albumin-to-creatinine ratio (uACR) captured as the proportion of patients who achieved nephropathy remission (uACR<30 mg/g of albumin/mg of creatinine) in an isolated urine sample over 12, 24 and 60 months.
  
  
  
  The study was approved by the local Institutional Review Board. This study represents the first RCT comparing RYGB plus BMT versus BMT alone for patients with T2DM with a BMI below 35 kg/m2.
  
  
  
  NCT01821508; Pre-results.
authors.affiliation: The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.
authors.forename: Ricardo Vitor
authors.initials: RV
authors.lastname: Cohen
authors.affiliation: Health Technology Assessment Unit, Oswaldo Cruz German Hospital, São Paulo, Brazil.
authors.forename: Tiago Veiga
authors.initials: TV
authors.lastname: Pereira
authors.affiliation: Health Research Unit, Oswaldo Cruz German Hospital, São Paulo, Brazil.
authors.forename: Cristina Mamédio
authors.initials: CM
authors.lastname: Aboud
authors.affiliation: The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.
authors.forename: Pedro Paulo de Paris
authors.initials: PP
authors.lastname: Caravatto
authors.affiliation: The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.
authors.forename: Tarissa Beatrice Zanata
authors.initials: TB
authors.lastname: Petry
authors.affiliation: The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.
authors.forename: José Luis Lopes
authors.initials: JL
authors.lastname: Correa
authors.affiliation: Research Institute Hcor, Heart Hospital, São Paulo, Brazil.
authors.forename: Carlos Aurélio
authors.initials: CA
authors.lastname: Schiavon
authors.affiliation: Health Research Unit, Oswaldo Cruz German Hospital, São Paulo, Brazil.
authors.forename: Mariangela
authors.initials: M
authors.lastname: Correa
authors.affiliation: The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.
authors.forename: Carlos Eduardo
authors.initials: CE
authors.lastname: Pompílio
authors.affiliation: The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.
authors.forename: Fernando Nogueira Quirino
authors.initials: FN
authors.lastname: Pechy
authors.affiliation: Diabetes Complication Research Centre, UCD Conway Institute, School of Medicine and Medical Science, University College Dublin, Dublin, Ireland.
authors.forename: Carel W
authors.initials: CW
authors.lastname: le Roux
mesh_terms: D000328:Adult; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D003925:Diabetic Angiopathies / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D015390:Gastric Bypass; D006801:Humans; D008297:Male; D009767:Obesity, Morbid / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D016896:Treatment Outcome
keywords: diabetes mellitus type 2; gastric bypass; metabolic surgery