Bariatric Surgery and Chronic Renal Disease

NCT05240443 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-02-15

No results posted yet for this study

Summary

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.

Conditions

  • Bariatric Surgery
  • Chronic Kidney Diseases
  • Obesity

Interventions

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.

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.

Sponsors & Collaborators

  • American College of Surgeons

    collaborator OTHER
  • McMaster Surgical Associates

    collaborator OTHER
  • McMaster University

    lead OTHER

Principal Investigators

  • Dennis Hong, MD MSc FRCSC · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-05-01
Completion
2023-06-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT05240443 on ClinicalTrials.gov