What are the effects of Roux-en-Y gastric bypass surgery (RYGB) vs best medical treatment on microalbuminuria in patients with type 2 diabetes, early-stage chronic kidney disease, and obesity?
In this randomized clinical trial of 100 patients randomly assigned to receive RYGB surgery vs best medical care, at 24-month follow-up, albuminuria remission occurred in 55% of patients after best medical treatment and 82% of patients after Roux-en-Y gastric bypass. The geometric mean urinary albumin-to-creatinine ratio was 55% lower in the Roux-en-Y gastric group, but there was no difference in serious adverse events.
Roux-en-Y gastric bypass is a safe and more effective means of achieving remission of albuminuria and early-stage chronic kidney disease than best medical treatment in patients with type 2 diabetes, microalbuminuria, and obesity.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT01821508
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Cohen RV, Pereira TV, Aboud CM, et al. 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. JAMA Surg. Published online June 03, 2020. doi:10.1001/jamasurg.2020.0420
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