1. Patients who underwent Roux-en-Y gastric (RYGB) surgery had higher rates of microalbuminuria remission when compared to those who received only medical treatment at 24 months post-intervention.
2. Patients who underwent RYGB surgery also showed improvements in metabolic control outcomes (HbA1C, LDL-C, triglycerides, and change in total body weight) when compared to those who received only medical treatment, while having a similar safety profile.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The management of type 2 diabetes (T2D) and chronic kidney disease (CKD) through pharmacotherapy has shown promising advancements in recent years. However, despite these improvements in the best available medical therapies, many obese T2D patients still suffer from progressive CKD. This study compared the effects between RYGB surgery and the best medical therapies on lowering microalbuminuria in obese T2D patients with early CKD. Findings suggest that 24 months post-intervention, RYGB surgery was more effective than the best medical treatments at reducing microalbuminuria and early CKD severity in a population of obese type 2 diabetics while maintaining a comparable safety profile. Through their sex-stratified, computer-generated randomizer, the researchers were able to successfully obtain two groups with comparable demographic and clinical baseline characteristics. In addition, follow-ups were frequent, but still maintained a high patient turnout throughout the study. A limitation worth noting is that patients in the RYGB group were not exclusively treated with the surgical intervention. Indeed, many patients who underwent RYGB surgery were also administered antihypertensives and glucose-regulating medications, as needed, similar to the medical treatment-only group.
Relevant Reading: Effect of Bariatric Surgery on CKD Risk
In-Depth [randomized controlled trial]: This randomized clinical trial enrolled 100 patients from a single center between April 1, 2013 and March 31, 2016. Patients were between 18 and 65 years of age with pre-established microalbuminuria, T2D, and obesity. More specifically, patients were enrolled if they met the following criteria: urinary albumin-creatinine ratio (uACR) greater than 30 mg/g, T2D with HbA1C <12%, BMI of 30 to 35 kg/m2, and classification of having stage G1 to G3 and A2 to A3 CKD. Patients were randomized to the best medical treatment (BMT) or RYGB surgery intervention group. All surgeries were performed by the same surgeon. The primary outcome was remission of uACR levels, defined as levels <30 mg/g. Secondary outcomes included, but were not limited to, HbA1C levels, mean percentage change in body weight, and occurrence of adverse events. Patients were assessed at one and four weeks after being randomized, and then in three-month intervals until the end of the 24-month period. After 24 months, an intention-to-treat analysis indicated that uACR remission was achieved in 82% of RYGB patients (95% confidence interval [CI], 72 to 93%) compared to 55% in BMT patients (95% CI, 39 to 70%; P = 0.006). In addition, HbA1C levels were reduced in the RYGB group compared to the BMT group with a mean difference of -0.54% (95% CI, -1.07 to -0.004; P = 0.048). Mean percentage change in total body weight in the RYGB group was -25.4% (95% CI, -26.9 to -23.8%) and -4.5% in the BM group (95% CI, -6.1 to -3.1%). Furthermore, serious adverse events occurred with equal frequency between the RYGB (13%) and BMT (13%) groups (P > 0.99), suggesting a comparable safety profile. All in all, RYGB surgery was more effective than BMT at achieving uACR remission, while also improving metabolic targets in obese type 2 diabetics with CKD.
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