A Phase 2/3 interventional study of Diet and exercise and Bariatric Surgery in Chronic Kidney Disease and Obesity, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 19 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-10-27.
Sponsored by The Cleveland Clinic · Phase 2/3, Interventional, and Treatment
Obesity is an established risk factor for development and progression of kidney disease. Intentional weight loss in people without kidney disease results in an improvement in diabetes, blood pressure, cholesterol, cardiovascular disease and overall death rates. The investigators do not know whether this holds true in patients with chronic kidney disease. In the proposed pilot study, the investigators will analyze if kidney function stabilizes after weight loss interventions in obese kidney disease patients and the mechanisms that might mediate this beneficial effect. If weight loss in kidney disease patients results in stabilization of kidney function, this would provide an opportunity to conduct a long-term prospective study to analyze the sustained benefits of weight loss in kidney disease patients.
Specific aim 1:
To ascertain the effects of lifestyle modification or bariatric surgery on urinary protein excretion and renal function among obese CKD patients.
Hypothesis: Weight loss attained through either lifestyle modification or surgical intervention will result in lowering of urinary protein excretion and stabilization of renal function among obese CKD patients.
Specific aim 2:
To identify the mechanism that mediates the change in urinary protein excretion and renal function among obese CKD patients undergoing lifestyle modification or bariatric surgery.
Hypothesis: Weight loss attained through either lifestyle modification or surgical intervention will result in amelioration of endothelial dysfunction, inflammation, insulin resistance and an increase in High Molecular Weight (HMW) adiponectin levels that then mediate the improvement in urinary protein excretion and renal function among obese CKD patients.
In this non-randomized prospective study, three different groups of patients will be enrolled. Group 1 will include obese chronic kidney disease (CKD) patients undergoing lifestyle modifications, Group 2 will include obese CKD patients undergoing bariatric surgery and Group 3 will include obese CKD patients undergoing no specific weight loss interventions (control group).
The lifestyle group will undergo supervised exercise training 5 days per week and follow hypocaloric diet based on the recommendations by a dietitian for 12 weeks. The exercise training will consist of walking, running on a treadmill and stationary cycling on a cycle ergometer. Patients will undergo adipokines, markers of inflammation,insulin resistance, renal function, bioimpedance analysis,DEXA measurement at baseline, 3- and 6-month intervals. CKD patients who undergo bariatric surgery and the control group will also undergo same blood tests, renal function studies and body composition studies at baseline, 3- and 6-month intervals.
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Exclusion Criteria:
This group will undergo supervised exercise training 5 days per week and follow hypocaloric diet for 12 weeks. All exercise training sessions will be supervised by an Exercise Physiologist or Research Nurse, and will be conducted in the Exercise Physiology Laboratory at the CCF CRU. Exercise training will consist of walking, running on a treadmill, and stationary cycling on a cycle ergometer. Each exercise session will include a brief standardized warm-up and cool-down that include a series of stretching exercises.
Behavioral: Diet and exercise
This group will include CKD patients who undergo bariatric surgery.
Procedure: Bariatric Surgery
This group will not undergo any form of weight loss intervention
This group will follow a hypocaloric diet and supervised exercise training for 12 weeks.
Patients will undergo bariatric surgery
Changes in renal function using iothalamate studies and urinary protein excretion using 24 hour urinary studies
Weight loss attained through either lifestyle modification or surgical intervention will result in lowering of urinary protein excretion and stabilization of renal function among obese CKD patients.
Time frame: 6 months
Changes in markers of insulin resistance and inflammation, adipokines, and body composition.
Weight loss attained through either lifestyle modification or surgical intervention will result in amelioration of endothelial dysfunction, inflammation, insulin resistance and an increase in HMW adiponectin levels that then mediate the improvement in urinary protein excretion and renal function among obese CKD patients.
Time frame: 6 months
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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