Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease
Condition: Chronic Kidney Disease; Obesity
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Weight Loss
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Diet and exercise; Bariatric Surgery
Intervention type(s): Behavioral; Procedure
Intervention description(s): This group will follow a hypocaloric diet and supervised exercise training for 12 weeks.; Patients will undergo bariatric surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Chronic Kidney Disease