Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease (OBESE-DKD)
Diabetes Mellitus, Type 2, Kidney Disease, Chronic, Kidney Injury
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Diabetes Mellitus, Obesity, Metabolic surgery, Gastric bypass, Diabetic kidney disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 / Locations
- Centro especializado em Obesidade e Diabetes do Hospital Alemão Oswaldo CruzRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
RYGB (intervention arm)
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.