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. Issue 1 (11th January 2017)

• Record Type: Journal Article
• Authors: Cohen, Ricardo Vitor; Pereira, Tiago Veiga; Aboud, Cristina Mamédio; Caravatto, Pedro Paulo de Paris; Petry, Tarissa Beatrice Zanata; Correa, José Luis Lopes; Schiavon, Carlos Aurélio; Correa, Mariangela; Pompílio, Carlos Eduardo; Pechy, Fernando Nogueira Quirino; Roux, Carel le
• Is Part Of: BMJ open. Volume 7:Issue 1(2017)
• Publication Date: 2017-01-11
• Subjects: gastric bypass -- diabetes mellitus type 2 -- metabolic surgery; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2016-013574
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: 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). Purpose: 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/m 2 . Methods and analysis: This study design includes a unicentric randomised unblinded controlled trial. 100 patients (BMI from 30 to 34.9 kg/m 2 ) 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. Ethics and dissemination: 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/m 2 . Trial registration number: NCT01821508 ; Pre-results.