Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 1/1/2014 |
| Start Date: | August 2010 |
| End Date: | December 2014 |
| Contact: | Sankar D Navaneethan, M.D. |
| Email: | navanes@ccf.org |
| Phone: | 216-636-9230 |
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.
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.
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.
Inclusion Criteria:
1. Adult (age > 18 years) individuals with BMI > 35 kg/m2
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:
1. History of prior and functioning kidney transplant or on dialysis
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
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