Study:
Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease
Rationale:
n/a
Purpose:
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.
Study Status: Recruiting
Recruiting:
Sankar Navaneethan, M.D. 216-636-9230 navanes@ccf.org
| Condition |
Intervention |
Phase |
Chronic Kidney Disease Obesity |
Behavioral: Diet and exercise Procedure: Bariatric Surgery |
Phase 2/Phase 3 |
Verified by
The Cleveland Clinic
June, 2011
Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov identifier: NCT01180101
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
Sankar Navaneethan, M.D.., Principal Investigator