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Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01180101
First received: August 10, 2010
Last updated: January 6, 2014
Last verified: July 2013

August 10, 2010
January 6, 2014
August 2010
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01180101 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease
Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Obesity
  • 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
  • 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.
    Intervention: Behavioral: Diet and exercise
  • Active Comparator: Bariatric Surgery Group
    This group will include CKD patients who undergo bariatric surgery.
    Intervention: Procedure: Bariatric Surgery
  • No Intervention: CKD Group (control)
    This group will not undergo any form of weight loss intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
December 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01180101
10-380
No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Sankar Navaneethan, M.D. The Cleveland Clinic
The Cleveland Clinic
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP