Bariatric Surgery and Chronic Renal Disease
NCT05240443 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2022-02-15
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 - 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
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