Clinical trial NCT04626323: Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease
Official title: Open, Randomized, Unicenter Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Kidney Disease, Chronic
Kidney Injury
Keywords: Diabetes Mellitus, Type 2
Diabetes Mellitus
Obesity
Metabolic surgery
Gastric bypass
Diabetic kidney disease
Lead sponsor: Hospital Alemão Oswaldo Cruz
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Mean differenceGlomerular filtration rate (GFR)
timeFrame: At 12 and 36 months after randomization
Secondary outcomes:
measure: Change in twenty-four hour urinary albumin/protein excretion
timeFrame: From baseline to 12 and 36 months
measure: Improvements in micro- or macroalbuminuria
timeFrame: From baseline to 12 and 36 months
measure: Change in CKD stage and CKD prognostic risk
timeFrame: From baseline to 12 and 36 months
measure: Change in GFR, eGFR and 24 hr creatinine clearance
timeFrame: From baseline to 12 and 36 months
measure: Proportion of participants with ≥30%, ≥40%, and ≥50% reduction in GFR measurements
timeFrame: From baseline to 12 and 36 months
measure: Decline in eGFR, sustained low eGFR, kidney transplantation, maintenance dialysis, and kidney death
timeFrame: Time to occurrence (from baseline)
measure: Maintenance dialysis, kidney transplantation, kidney death, and GFR < 15 ml/min
timeFrame: At 12 and 36 months after randomization
measure: Change in body weight
timeFrame: From baseline to 12 and 36 months
measure: Change in body mass index
timeFrame: From baseline to 12 and 36 months
measure: Change in waist circumference
timeFrame: From baseline to 12 and 36 months
measure: Medications to maintain optimal diabetes and blood pressure control
timeFrame: From baseline to 12 and 36 months
measure: Change in fasting glucose
timeFrame: From baseline to 12 and 36 months
measure: Change in HbA1c
timeFrame: From baseline to 12 and 36 months
measure: Change in basal insulin
timeFrame: From baseline to 12 and 36 months
measure: Change in homeostasis model assessment (HOMA) scores
timeFrame: From baseline to 12 and 36 months
measure: Remission in type 2 diabetes
timeFrame: At 12 and 36 months after randomization
measure: Change in blood pressure
timeFrame: From baseline to 12 and 36 months
measure: Hypoglycemic adverse events
timeFrame: From baseline to 12 and 36 months
measure: Changes in total cholesterol, triglycerides, LDL and HDL levels
timeFrame: From baseline to 12 and 36 months
measure: Number of participants achieving LDL < 100 mg/dL and HDL > 40mg/dL
timeFrame: From baseline to 12 and 36 months
measure: Changes in serum calcium and phosphorus,
timeFrame: From baseline to 12 and 36 months
measure: Change in parathyroid hormone (PTH)
timeFrame: From baseline to 12 and 36 months
measure: Change in mineral bone density
timeFrame: From baseline to 12 and 36 months
measure: Change in quality of life
timeFrame: From baseline to 12 and 36 months
measure: Adverse events
timeFrame: From baseline to 12 and 36 months
measure: Acute kidney injury
timeFrame: From baseline to 12 and 36 months
measure: Adverse cardiovascular events (nonfatal stroke, nonfatal MI, cardiovascular death)
timeFrame: From baseline to 12 and 36 months
measure: Mortality
timeFrame: From baseline to 12 and 36 months
measure: Days hospitalized
timeFrame: From baseline to 12 and 36 months
measure: Change in urinary volume
timeFrame: From baseline to 12 and 36 months
measure: Change in calcium and oxalate excretion
timeFrame: From baseline to 12 and 36 months
measure: High sensitivity c-reactive protein
timeFrame: From baseline to 12 and 36 months
measure: Change in muscle strength
timeFrame: From baseline to 12 and 36 months
measure: Kidney volumes
timeFrame: From baseline to 12 and 36 months
measure: Change in ventricular mass
timeFrame: From baseline to 12 and 36 months
measure: Change in ejection fraction
timeFrame: From baseline to 12 and 36 months
measure: Costs of care and health care utilization
timeFrame: From baseline to 12 and 36 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro especializado em Obesidade e Diabetes do Hospital Alemão Oswaldo Cruz
state: São Paulo
Study officials:
affiliation: Oswaldo Cruz German Hospital
name: Ricardo V Cohen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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