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

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Cohen reported receiving grants from Johnson & Johnson Medical Brasil during the conduct of the study. Dr Petry reported receiving grants from Johnson & Johnson Medical Brasil during the conduct of the study. Dr Schiavon reported receiving grants from Ethicon Inc and personal fees from Johnson & Johnson Brasil outside the submitted work. Dr Pompilio reported receiving grants from Johnson & Johnson Medical Brasil during the conduct of the study. Dr Sarian reported receiving grants from Johnson & Johnson Medical Brasil during the conduct of the study. Dr le Roux reported receiving grants from Science Foundation Ireland, Health Research Board, European Federation for Study of Diabetes, and the Swedish Research Council during the conduct of the study and receiving honorarium for lectures and scientific advisory board from Novonordisk, GI Dynamics, Sanofi, Johnson & Johnson Brasil, Keyron, Herbalife, and Boehringer Ingelheim outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram of Screening, Enrollment, and 24-Month Follow-up in the Microvascular Outcomes after Metabolic Surgery (MOMS) Trial

The intention-to-treat population included 49 patients in the best medical treatment (BMT) group and 51 patients in the Roux-en-Y gastric bypass (RYGB) group, whereas the safety population included 46 patients in each group. BMT indicates best medical treatment; GAD, glutamic acid decarboxylase; and RYGB, Roux-en-Y gastric bypass.

Figure 2.. Albuminuria Remission Rates at 12 and 24 Months of Follow-up and Longitudinal Biochemical Measures of Urinary Albumin-Creatinine Ratio (uACR) and Metabolic Control

A, Rates of albuminuria remission (uACR

Figure 3.. Adverse Events

Common adverse events that occurred in 5% or more of patients in the Roux-en-Y gastric bypass (RYGB) arm. Circles and triangles represent the proportion of patients who had adverse events in each arm. Analysis was per protocol, with 46 patients per group. Circles denote proportions for the best medical treatment, and triangles display the corresponding estimates in the RYGB group. Adverse events were ranked by the odds ratio (OR). Squares represent the OR computed by an exact logistic regression model. Horizontal lines depict 95% CIs around the point estimate. Upper limits for the ORs were truncated at 1000 when estimated values exceed the length of the horizontal axis. BMT indicates best medical treatment; GI, gastrointestinal; RTI, respiratory tract infection.