Bariatric Surgery and Chronic Renal Disease (BARICADE)

February 13, 2022 updated by: Dennis Hong MD, McMaster University

Effect of Bariatric Surgery on Chronic Renal Disease (BARICADE): A Pilot Randomized Controlled Trial

Obesity can be a major driver for the development of chronic kidney disease (CKD), which is a leading cause of death and significant loss in quality of life. A growing body of evidence has shown bariatric (metabolic) surgery as a novel approach to reduce the progression of CKD and reduce morbidity with sustained weight loss. This pilot trial will inform the design and execution of a large RCT that could determine the efficacy of bariatric surgery in the treatment of patients with CKD in the context of obesity. Ultimately, the results have the potential to influence guidelines that may deem bariatric surgery as a viable treatment option for CKD and reduce the morbidity from this chronic condition and inform clinical practice.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity is a major driver for the development of CKD, which is a leading cause of death and greatly reduces one's quality of life. With a global prevalence of 9.1% (7.2% in Canada), CKD affects an estimated 13.6% of the American population and was associated with over $50 billion in healthcare costs, with an additional $30 billion in costs associated with end-stage renal disease (ESRD). Moreover, with an aging Canadian population, the prevalence of CKD is expected to rise over the coming years with patients progressing to higher disease burdens. This, in part, has led to a substantial increase in renal replacement therapy by means of dialysis or kidney transplant by 43.1% since 1990. Obesity is also an important modulatory factor in the development of poor outcomes as a result of CKD and has been linked to an increased rate of progression from CKD towards kidney failure. The most common comorbidities in patients with CKD were hypertension, diabetes, heart failure, chronic pulmonary disease, and atrial fibrillation and in Canada, 25% of patients with CKD have at least 3 or more comorbidities which too are associated with an increased risk of hospitalization and early death. Most worryingly, unlike other non-communicable diseases today, the age-standardized mortality for CKD has not declined over the past decades. Therefore, innovative strategies are of timely importance to reduce mortality and morbidity in patients with CKD and thus urgently needed, especially in patients with multiple comorbidities and targeting weight loss is a promising avenue to find novel treatment options.

Bariatric surgery has been shown to not only facilitate sustained weight loss in patients with obesity, but also independently improve cardiac risk factors such as dyslipidemia, hypertension, and type 2 diabetes mellitus. It has also been shown to reverse glomerular hyperfiltration and lower proteinuria in patients with obesity and normal kidney function and delay the need for renal transplantation in patients with ESRD. Moreover, the protective benefit of bariatric surgery has been shown to reduce risk of CKD progression for up to seven years after intervention in observational studies. However, current guidelines do not address a role for bariatric surgery in the management of patients with obesity and CKD.

Given the poor outcomes with patients with obesity and CKD, a RCT to assess the efficacy and safety of bariatric surgery as an intervention for patients with CKD is of timely importance. The present proposed pilot RCT of bariatric surgery versus medical management alone for patients with morbid obesity and CKD in order to assess whether a large, multi-centre, efficacy trial is feasible. The results of the proposed pilot study will thus inform the design of a larger RCT in this patient population.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
        • Principal Investigator:
          • Dennis Hong, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yung Lee, MD
        • Sub-Investigator:
          • Michael Walsh, MD
        • Sub-Investigator:
          • Aristithes G Doumouras, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient age >18
  • Body mass index > 40 (or > 35 kg/m2 for patients with comorbidities)

  • Diagnosis of CKD stage III (G3a or A2) defined as the presence of any of the following:

    1. glomerular filtration rate (GFR) under 60 mL/min/1.73 m2 as estimated from serum creatinine or cystatin C with the CKD-EPI equation
    2. ACR > 30 mg/g
  • Patient is deemed eligible to undergo bariatric surgery according to Ontario Bariatric Network (OBN) guidelines [contradictions to OBN guidelines include non-Ontario resident, age >70 years, history of cancer <2 years, current substance use disorder, accessed palliative care, previous organ transplant (liver, heart, or lungs), active cardiac disease, major revascularization procedures within 6 months, or severe liver disease with ascites <1 year]

Exclusion Criteria:

  • Hospital admission for kidney failure or acute kidney injury within 30 days of enrollment
  • Documented GFR > 60 mL/min/1.73 m2 or ACR < 30 mg/g within 30 days of enrollment
  • Documented confounders of kidney function measurement such as urinary tract infection or use of creatinine elevating medications or use of medications which interfere with measurement
  • Contradiction to OBN guidelines including non-Ontario resident, age >70 years, history of cancer <2 years, current substance use disorder, accessed palliative care, previous organ transplant (liver, heart, or lungs), active cardiac disease, major revascularization procedures within 6 months, or severe liver disease with ascites <1 year
  • Life expectancy <2 years due to non-CKD causes OR Untreated or inadequately treated psychiatric illness OR Risk of general anesthesia deemed too excessive OR Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bariatric Surgery + Medical Management for Chronic Kidney Disease
The intervention group will include medical management and bariatric surgery, which will consist of Roux-en-Y gastric bypass or sleeve gastrectomy performed according to local practice standards. Medical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD.
Procedure: Bariatric Surgery + Medical Management of CKD.
The intervention group will include medical management and bariatric surgery, which will consist of Roux-en-Y gastric bypass or sleeve gastrectomy performed according to local practice standards. Medical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD.
Active Comparator: Medical Management for Chronic Kidney Disease
Medical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD.
Other: Medical Management for CKD
Medical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 6 months
Time Frame: Month 6
Month 6
Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 12 months
Time Frame: Month 12
Month 12
Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 18 months
Time Frame: Month 18
Month 18
Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 6 months
Time Frame: Month 6
Month 6
Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 12 months
Time Frame: Month 12
Month 12
Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 18 months
Time Frame: Month 18
Month 18
Creatine Clearance (units: mL/min) at 6 months
Time Frame: Month 6
Month 6
Creatine Clearance (units: mL/min) at 12 months
Time Frame: Month 12
Month 12
Creatine Clearance (units: mL/min) at 18 months
Time Frame: Month 18
Month 18
Serum Creatinine (units: μmol/L) at 6 months
Time Frame: Month 6
Month 6
Serum Creatinine (units: μmol/L) at 12 months
Time Frame: Month 12
Month 12
Serum Creatinine (units: μmol/L) at 18 months
Time Frame: Month 18
Month 18
Serum Cystatin C (units: mg/L) at 6 months
Time Frame: Month 6
Month 6
Serum Cystatin C (units: mg/L) at 12 months
Time Frame: Month 12
Month 12
Serum Cystatin C (units: mg/L) at 18 months
Time Frame: Month 18
Month 18
Urine Albumin-Creatine Ratio (units: mg/g) at 6 months
Time Frame: Month 6
Month 6
Urine Albumin-Creatine Ratio (units: mg/g) at 12 months
Time Frame: Month 12
Month 12
Urine Albumin-Creatine Ratio (units: mg/g) at 18 months
Time Frame: Month 18
Month 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight and height will be combined to report BMI in kg/m^2 at 6 months
Time Frame: Month 6
Month 6
Weight and height will be combined to report BMI in kg/m^2 at 12 months
Time Frame: Month 12
Month 12
Weight and height will be combined to report BMI in kg/m^2 at 18 months
Time Frame: Month 18
Month 18
Recruitment Rate (60 patients will be recruited at an average recruitment rate of 1.25 patients per site per month.)
Time Frame: Month 6
60 patients will be recruited at an average recruitment rate of 1.25 patients per site per month.
Month 6
Intervention Administration Rate
Time Frame: Month 6
>80% of patients randomized to the intervention arm will undergo bariatric surgery within 30 days of randomization.
Month 6
Crossover rate between control and intervention arm
Time Frame: Month 6
Month 6
Number of patients adhering to study treatments
Time Frame: Month 6
Patients will be monitored and asked about adherence at follow-ups.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

American College of Surgeons
McMaster Surgical Associates

Investigators

  • Principal Investigator: Dennis Hong, MD MSc FRCSC, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

February 13, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 13, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-14388-GRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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