Status:
COMPLETED
Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease
Lead Sponsor:
The Cleveland Clinic
Conditions:
Chronic Kidney Disease
Obesity
Eligibility:
All Genders
19-99 years
Phase:
PHASE2
PHASE3
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,...
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, Grou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01180101
Start Date
August 1 2010
End Date
December 1 2014
Last Update
October 27 2016
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195