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

NCT04626323 | Unknown Phase 2 DMC

• 2 other identifiers: OBESE-DKDCAAE - 37013420500000070
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Mean differenceGlomerular filtration rate (GFR)

  Mean difference in GFR between BMT and RYGB at the pre-specified time points of 12 and 36 months after randomization

  At 12 and 36 months after randomization

Secondary Outcomes (37)

• Change in twenty-four hour urinary albumin/protein excretion

  From baseline to 12 and 36 months

• Improvements in micro- or macroalbuminuria

  From baseline to 12 and 36 months

• Change in CKD stage and CKD prognostic risk

  From baseline to 12 and 36 months

• Change in GFR, eGFR and 24 hr creatinine clearance

  From baseline to 12 and 36 months

• Proportion of participants with ≥30%, ≥40%, and ≥50% reduction in GFR measurements

  From baseline to 12 and 36 months

Study Arms (2)

RYGB (intervention arm)

EXPERIMENTAL

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.

Procedure: Roux-en-Y gastric bypass; Drug: Best medical treatment

BMT (control arm).

ACTIVE COMPARATOR

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.

Drug: Best medical treatment

Interventions

Roux-en-Y gastric bypass PROCEDURE

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

Also known as: RYGB

RYGB (intervention arm)

Best medical treatment DRUG

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).

Also known as: BMT

BMT (control arm).; RYGB (intervention arm)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Alemão Oswaldo Cruz: lead

Study Sites (1)

Centro especializado em Obesidade e Diabetes do Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, 01323-020, Brazil

RECRUITING

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Related Links

• Obesity and Diabetes Center
• Oswaldo Cruz German Hospital

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Diabetes Mellitus; Obesity; Diabetic Nephropathies

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Diabetes Complications

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Ricardo V Cohen, MD, PhD

  Oswaldo Cruz German Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina M Aboud, RN, MSc

CONTACT

+551135491187; cmamedio@haoc.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ricardo Vitor Cohen, MD, PhD

Model Details: 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).

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 12, 2020
• Study Start: May 25, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)