Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease
60 patients around the world
Available in Brazil
This will be an open-label, randomized trial involving sixty (60) patients with DKD and
obesity who will undergo RYGB (intervention arm) or receive BMT (control arm).
Thirty (30) obese patients with DKD will undergo gastric bypass. Patients will also receive
standard of care medical therapy for DKD (ACEI or ARB + SGLT2i) and T2DM (metformin,
glitazones, incretin therapy - DPP4 inhibitor and GLP-1 analogs - and insulin, if necessary).
Other comorbidities, such as hypertension and dyslipidemia, will be treated according to the
latest recommendations of the ADA. The surgical procedure will consist of a laparoscopic
surgery performed by an experienced surgeon (approximately 6000 bariatric surgeries), who is
accredited as surgeon of excellence by the Brazilian Society of Bariatric and Metabolic
Surgery and Surgical Review and Surgical Review Corporation program since 2009.
Thirty (30) obese patients with DKD will undergo best medical treatment for DKD (ACEI or ARB
+ SGLT2i) and T2DM (metformin, glitazones, incretin therapy - DPP4 inhibitor and GLP-1
analogs - and insulin, if necessary). Other comorbidities, such as hypertension and
dyslipidemia, will be treated according to the latest recommendations of the ADA.
Regarding medication therapy: Metformin will be maintained in the postoperative period while
fasting glycemia is above 100 mg/dL unless contraindicated. Anti-antihypertensive drugs and
medications for dyslipidemia will be maintained in the postoperative period, unless
contraindicated. Micronutrient supplementation (vitamins and mineral salts) will be
prescribed to all patients undergoing metabolic surgery. Patients allocated to the control
group will receive the same supplementation if necessary.
Hospital Alemão Oswaldo Cruz
1Research sites
60Patients around the world
This study is for people with
Diabetes
Diabetes mellitus type 2
Renal disease
Chronic kidney disease
Requirements for the patient
To 70 Years
All Gender
Medical requirements
Sites
Hospital Alemão Oswaldo Cruz
Recruiting
R. Treze de Maio, 1815 - Bela Vista, São Paulo - SP, 01323-020, Brazil