Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease
NCT ID: NCT01180101
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
37 participants
INTERVENTIONAL
2010-08-31
2014-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lifestyle modification group
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.
Diet and exercise
This group will follow a hypocaloric diet and supervised exercise training for 12 weeks.
Bariatric Surgery Group
This group will include CKD patients who undergo bariatric surgery.
Bariatric Surgery
Patients will undergo bariatric surgery
CKD Group (control)
This group will not undergo any form of weight loss intervention
No interventions assigned to this group
Interventions
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Diet and exercise
This group will follow a hypocaloric diet and supervised exercise training for 12 weeks.
Bariatric Surgery
Patients will undergo bariatric surgery
Eligibility Criteria
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Inclusion Criteria
2. Patients with stage III CKD (eGFR 30-59 ml/min and with or without microalbuminuria or proteinuria)
3. Individuals who are eligible for bariatric surgery, based on National Institutes of Health and clinical criteria (BMI \> 40 kg/m2 BMI \> 35 kg/m2 with co-morbidities and \> 18 years of age), and do not have any health related or psychiatric contraindications for the surgery (for bariatric surgery group only)
Exclusion Criteria
2. Cardiovascular conditions including significant known coronary artery disease (recent PCI or CABG within last 6 months), uncompensated congestive heart failure and/or EF \<30%, history of stroke (within last 6 months), or uncontrolled hypertension (defined as SBP \> 180 mm Hg or DBP \> 110 mm Hg).
3. HbA1C \>8.0%
4. Hemoglobin \<10 g/dl or hematocrit \<30 (within the last 6 months)
5. Presence of active inflammatory disease such as AIDS, hepatitis B or C, or other active inflammatory diseases such as vasculitis
6. Patient being treated for malignancy (excluding basal or squamous cell carcinoma of the skin)
7. Patients taking anti-inflammatory medication such as NSAIDS except aspirin \< 325 mg/day over the past 30 days, or on any dose of prednisone therapy
8. On other study drug protocols
9. Patient on beta-blocker therapy - only for diet/exercise group
10. Patients can be on Angiotensin converting enzyme inhibitors/Angiotensin receptor blocker therapy that was started at least 3 months prior to the enrollment. New Angiotensin converting enzyme inhibitors/Angiotensin receptor blocker therapy initiation will not be allowed during the study period
19 Years
99 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Sankar Navaneethan, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Other Identifiers
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10-380
Identifier Type: -
Identifier Source: org_study_id