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Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease, Obesity

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Diet and exercise

Bariatric Surgery

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Obesity, Chronic Kidney Disease

Eligibility Criteria

19 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Lifestyle modification group

Bariatric Surgery Group

CKD Group (control)

Arm Description

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.

This group will include CKD patients who undergo bariatric surgery.

This group will not undergo any form of weight loss intervention

Outcomes

Primary Outcome Measures

Changes in renal function using iothalamate studies and urinary protein excretion using 24 hour urinary studies

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.

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.

Full Information

NCT ID

NCT01180101

First Posted

August 10, 2010

Last Updated

October 26, 2016

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01180101

Brief Title

Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease

Official Title

Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, Obesity

Keywords

Obesity, Chronic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle modification group

Arm Type

Active Comparator

Arm Description

Arm Title

Bariatric Surgery Group

Arm Type

Active Comparator

Arm Description

This group will include CKD patients who undergo bariatric surgery.

Arm Title

CKD Group (control)

Arm Type

No Intervention

Arm Description

This group will not undergo any form of weight loss intervention

Intervention Type

Behavioral

Intervention Name(s)

Diet and exercise

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Bariatric Surgery

Intervention Description

Patients will undergo bariatric surgery

Primary Outcome Measure Information:

Title

Changes in renal function using iothalamate studies and urinary protein excretion using 24 hour urinary studies

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Changes in markers of insulin resistance and inflammation, adipokines, and body composition.

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sankar Navaneethan, M.D.

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

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Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease

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