Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease - Full Text View

Sponsor:	The Cleveland Clinic
Collaborator:	Sankar D Navaneethan MD
Information provided by (Responsible Party):	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01180101

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.

Condition	Intervention	Phase
Chronic Kidney Disease Obesity	Behavioral: Diet and exercise Procedure: Bariatric Surgery	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Exercise and Physical Fitness Kidney Failure Obesity Weight Control Weight Loss Surgery

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

Changes in renal function using iothalamate studies and urinary protein excretion using 24 hour urinary studies [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Changes in markers of insulin resistance and inflammation, adipokines, and body composition. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Weight loss attained through either lifestyle modification or surgical intervention will result in amelioration of endothelial dysfunction, inflammation, insulin resistance and an increase in HMW adiponectin levels that then mediate the improvement in urinary protein excretion and renal function among obese CKD patients.

Estimated Enrollment:	45
Study Start Date:	August 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Behavioral: Diet and exercise This group will follow a hypocaloric diet and supervised exercise training for 12 weeks.
Active Comparator: Bariatric Surgery Group This group will include CKD patients who undergo bariatric surgery.	Procedure: Bariatric Surgery Patients will undergo bariatric surgery
No Intervention: CKD Group (control) This group will not undergo any form of weight loss intervention

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult (age > 18 years) individuals with BMI > 35 kg/m2
Patients with stage III CKD (eGFR 30-59 ml/min and with or without microalbuminuria or proteinuria)
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:

History of prior and functioning kidney transplant or on dialysis
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).
HbA1C >8.0%
Hemoglobin <10 g/dl or hematocrit <30 (within the last 6 months)
Presence of active inflammatory disease such as AIDS, hepatitis B or C, or other active inflammatory diseases such as vasculitis
Patient being treated for malignancy (excluding basal or squamous cell carcinoma of the skin)
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
On other study drug protocols
Patient on beta-blocker therapy - only for diet/exercise group
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180101

Contacts

Contact: Sankar D Navaneethan, M.D.	216-636-9230	navanes@ccf.org
Contact: Michelle Garcia, R.N.	216-444-7753	garciam1@ccf.org

Locations

United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sankar Navaneethan, M.D. 216-636-9230 navanes@ccf.org
Contact: Michelle Garcia, R.N. 216-444-7753 garciam1@ccf.org

Sponsors and Collaborators

The Cleveland Clinic

Sankar D Navaneethan MD

Investigators

Principal Investigator:

Sankar Navaneethan, M.D.

The Cleveland Clinic

More Information

No publications provided

Responsible Party:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01180101 History of Changes
Other Study ID Numbers:	10-380
Study First Received:	August 10, 2010
Last Updated:	January 19, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

Obesity
Chronic Kidney Disease

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Obesity
Weight Loss
Urologic Diseases
Renal Insufficiency

Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on February 09, 2012