Related Experiment Video
Updated: Mar 9, 2026
Duodenal-Jejunal Bypass Surgery in Diet-Induced Obese Diabetic Mice
Published on: October 18, 2024
Microvascular Outcomes after Metabolic Surgery (MOMS) in patients with type 2 diabetes mellitus and class I obesity:
Ricardo Vitor Cohen1, Tiago Veiga Pereira2, Cristina Mamédio Aboud3
1The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.
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/m2.
Methods And Analysis:
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.
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/m2.
Trial Registration Number:
NCT01821508; Pre-results.
Insights
This study investigates Roux-en-Y gastric bypass (RYGB) plus best medical treatment (BMT) versus BMT alone for type 2 diabetes mellitus (T2DM) patients with a BMI of 30-34.9 kg/m². It assesses long-term microvascular outcomes, specifically diabetic nephropathy remission.
Area of Science:
- Endocrinology
- Metabolic Surgery
- Nephrology
Background:
- Randomized controlled trials (RCTs) demonstrate metabolic/bariatric surgery's efficacy in glycemic control for type 2 diabetes mellitus (T2DM).
- Limited level 1A evidence exists regarding surgery's impact on T2DM microvascular complications.
- Roux-en-Y gastric bypass (RYGB) is a common bariatric procedure.
Purpose of the Study:
- To evaluate the long-term effectiveness and safety of RYGB plus best medical treatment (BMT) compared to BMT alone.
- To determine the impact of RYGB on microvascular outcomes in T2DM patients with a body mass index (BMI) of 30-34.9 kg/m².
- To assess nephropathy remission rates as a primary microvascular outcome.
Main Methods:
- A unicentric, randomized, unblinded controlled trial design.
- 100 T2DM patients (BMI 30-34.9 kg/m²) randomly assigned to RYGB + BMT or BMT alone.
- Primary outcome: change in urine albumin-to-creatinine ratio (uACR) for nephropathy remission (uACR<30 mg/g) at 12, 24, and 60 months.
Main Results:
- This is a pre-results trial registration; no data are available.
- The study is ongoing and will provide crucial insights into surgical interventions for T2DM microvascular complications.
- The trial aims to establish evidence for RYGB in a lower BMI T2DM population.
Conclusions:
- This trial is the first RCT comparing RYGB + BMT versus BMT alone in T2DM patients with a BMI below 35 kg/m².
- It will provide essential data on the long-term efficacy and safety of RYGB for T2DM microvascular complication management.
- Findings could influence treatment guidelines for T2DM management in this specific patient group.
Related Concept Videos
01:22Diabetes Mellitus: Type 2 and Gestational
01:36Carbohydrate Metabolism
Starch accounts for approximately 60% of the carbohydrates consumed by humans. Since amylase enzymes cannot function in the stomach's acidic environment, starch can only be digested in the mouth and small intestine. Simple sugars are found naturally in milk and fruits in...
01:22Diabetes Mellitus: Overview and Type I Subtype
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
01:15Diabetes: Symptoms, Diagnosis, and Complications
01:26Oral Hypoglycemic Agents: Biguanides and Glitazones
01:20Pathophysiology of Diabetes
Type 1 diabetes is characterized by autoimmune-mediated destruction of pancreatic β cells, with environmental factors potentially triggering this process in genetically susceptible individuals. Despite many not having a family history, certain genes increase susceptibility,...