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Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease

NCT01180101 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-10-27

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Diet and exercise

This group will follow a hypocaloric diet and supervised exercise training for 12 weeks.

PROCEDURE

Bariatric Surgery

Patients will undergo bariatric surgery

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Sankar Navaneethan, M.D. · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2014-07-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01180101 on ClinicalTrials.gov