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
Female or male aged ≥30 and ≤70 years
Diabetic kidney disease as defined by an estimated glomerular filtration rate (eGFR) (as estimated by CKD-EPI creatinine + cystatin C equation)72 between 45-59l/min/1.73m2 and macroalbuminuria (≥ 300 mg/g) in a 24 hr urine sample
BMI ≥30-40 kg/m2
Fasting C-peptide over 1 ng/ml
Negative glutamic acid decarboxylase autoantibodies test
Patients having received accurate information about the surgery and requesting the procedure
Patients having understood and accepted the need for long-term medical and surgical follow-up
Effective method of contraception in women of child-bearing age
Signed informed consent document
Refusal to participate
Autoimmune diabetes/type 1 diabetes
Previous abdominal operations that would complicate a metabolic surgery or increase surgical risk
Previous malabsorptive and restrictive surgeries
Malabsorptive syndromes and inflammatory bowel disease
Significant and/or severe hepatic disease that may complicate metabolic surgery
Pregnancy or women of childbearing age without effective contraceptive
Recent history of neoplasia (< 5 years), except for non-melanoma skin neoplasms
History of liver cirrhosis, active chronic hepatitis, active hepatitis B or hepatitis C
Major cardiovascular event in the last 6 months
Current angina
Pulmonary embolism or severe thrombophlebitis in the last 2 years
Positive HIV serum testing
Mental incapacity or severe mental illness
Severe psychiatric disorders that would complicate follow-up after randomization
Alcoholism or illicit drug use
Uncontrolled coagulopathy
Participation in other clinical trials in the past 30 days
Inability to tolerate RAAS blockers and/or SGLT2i
Iodine allergy
History of acute kidney injury requiring renal replacement therapy
Dialysis dependency
Kidney transplantation
Use of immunosuppressive drugs, chemotherapy and/or radiotherapy
Any disorder which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
Sites
Hospital Alemão Oswaldo Cruz
Recruiting
R. Treze de Maio, 1815 - Bela Vista, São Paulo - SP, 01323-020, Brazil