Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Proven therapy for DKD is primarily limited to RAAS blockers and SLGT2i. Weight reduction has
the potential to become an additional and much needed treatment option. Of all the weight
reduction strategies metabolic surgery is suited to be the most effective. Yet no study has
of yet compared the effect of metabolic surgery against best medical treatment on the
progression of DKD. This pilot trial is designed to be the first determine the efficacy of
metabolic surgery in slowing progression of DKD as compared to best medical therapy. The
study design will address all the major limitations previously documented, including the
major dilemma of estimating versus measuring GFR. Of note, the study's design will allow its
sample size to be adjusted upward using an adaptive design if necessary, to achieve
statistical significance. It will also inform study design and sample size issues for all
future studies in this field. The payoff of establishing metabolic surgery as a new and
effective intervention to slow progression to ESRD would be great in terms of reducing
patient suffering and societal costs.
This will be an open-label, randomized trial involving sixty (60) patients with diabetic
kidney disease (DKD) and obesity who will undergo Roux-en-Y gastric bypass (RYGB) in the
intervention arm or receive best medical treatment (BMT) in the control arm.
The aim of this prospective, open, randomized study is to evaluate the efficacy and safety of
RYGB surgery versus best medical treatment on the progression of DKD in patients with type 2
diabetes and obesity.