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Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease

NCT04626323 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-05-28

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Kidney Disease, Chronic
  • Kidney Injury

Interventions

PROCEDURE

Roux-en-Y gastric bypass

1. Pneumoperitoneum closed with Veress needle 2. Identification of Treitz angle 3. Measurement of biliary loop (50 cm) 4. Bowel transection with linear stapler (white load) 5. Measurement of the alimentary limb (100 cm) 6. Laterolateral Entero-anastomoses (white load) 7. Construction of gastric pouch distant about 3 cm from the esophageal-gastric junction with stomach section in the small curvature. 8. Linear cutting anastomosis (gastrojejunostomy) from about 1 to 1.2 cm 9. Anastomosis integrity evaluation by methylene blue test and/or perioperative air. Expected surgical time: 60 minutes

DRUG

Best medical treatment

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).

Sponsors & Collaborators

  • Hospital Alemão Oswaldo Cruz

    lead OTHER

Principal Investigators

  • Ricardo V Cohen, MD, PhD · Oswaldo Cruz German Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04626323 on ClinicalTrials.gov