Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity

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 MEASURESThe 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 RELEVANCEAfter 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.

Characterization of the renal cortical transcriptome following Roux-en-Y gastric bypass surgery in experimental diabetic kidney disease

“…18 This study demonstrated that at 2-year follow-up in patients with T2DM, class I obesity (body mass index 30-35 kg/m 2 ) and mild-to-moderate DKD (urinary albumin-to-creatinine ratio (uACR) 3-30 mg/ mmol and eGFR >30 mL/min/1.73 m 2 ) microalbuminuria remission occurred in 82% (95% CI 72% to 93%) of patients after RYGB vs 54.6% (95% CI 39% to 70%) of patients after best medical treatment (p=0.006). 18 The potent glucose-lowering effects of Roux-en-Y gastric bypass surgery (RYGB) have been demonstrated to be complimented by improvements in blood pressure which may be mechanistically linked in part to a unique natriuretic effect of the procedure. 19 20 We have previously reported that RYGB effectively reduces albuminuria in the Zucker diabetic fatty (ZDF) rat in conjunction with evidence of improvements in glomerular histology and ultrastructure.…”

“…Second, we have recently collaborated in the Clinical Study on Metabolic Surgery Compared to the Best Clinical Treatment in Patients with Type 2 Diabetes Mellitus (MOMS ) RCT (NCT01821508). 18 This study demonstrated that at 2-year follow-up in patients with T2DM, class I obesity (body mass index 30–35 kg/m 2 ) and mild-to-moderate DKD (urinary albumin-to-creatinine ratio (uACR) 3–30 mg/mmol and eGFR >30 mL/min/1.73 m 2 ) microalbuminuria remission occurred in 82% (95% CI 72% to 93%) of patients after RYGB vs 54.6% (95% CI 39% to 70%) of patients after best medical treatment (p=0.006). 18 …”

Characterisation of the Renal Cortical Transcriptome Following Roux-en-Y Gastric Bypass Surgery in Experimental Diabetic Kidney Disease

“…Secondly, we have recently collaborated in the Clinical Study on Metabolic Surgery Compared to the Best Clinical Treatment in Patients with Type 2 Diabetes Mellitus ( MOMS ) RCT (NCT01821508). (18). This study demonstrated that at 2 year follow-up in patients with T2DM, Class I obesity (BMI 30-35kg/m 2 ) and mild-moderate DKD (albumin-to-creatinine ratio [uACR] 3-30mg/mmol and eGFR >30mL/min/1.73m 2 ) microalbuminuria remission occurred in 82% (95% CI=72-93%) of patients after RYGB versus 54.6% (95% CI=39-70%) of patients after best medical treatment (P=0.006).…”

“…This study demonstrated that at 2 year follow-up in patients with T2DM, Class I obesity (BMI 30-35kg/m 2 ) and mild-moderate DKD (albumin-to-creatinine ratio [uACR] 3-30mg/mmol and eGFR >30mL/min/1.73m 2 ) microalbuminuria remission occurred in 82% (95% CI=72-93%) of patients after RYGB versus 54.6% (95% CI=39-70%) of patients after best medical treatment (P=0.006). (18)…”

Can Metabolic Surgery Be Used to Improve Access to and Outcomes of Kidney Transplantation?

“…Most studies were small, single center, and observational with limited follow-up. Randomized controlled trials (RCTs) of metabolic surgery in people with kidney disease are limited to early-stage chronic kidney disease (6). Abdominal surgeries are challenging in people on peritoneal dialysis; differences in outcomes of pre-transplant metabolic surgery between dialysis modalities were not explored.…”