Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease

NCT01180101 | Completed Phase 2

• 1 other identifier: 10-380
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Obesity

Keywords

Obesity; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (3)

Lifestyle modification group

ACTIVE COMPARATOR

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

Bariatric Surgery Group

ACTIVE COMPARATOR

This group will include CKD patients who undergo bariatric surgery.

Procedure: Bariatric Surgery

CKD Group (control)

NO INTERVENTION

This group will not undergo any form of weight loss intervention

Interventions

Diet and exercise BEHAVIORAL

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

Lifestyle modification group

Bariatric Surgery PROCEDURE

Patients will undergo bariatric surgery

Bariatric Surgery Group

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Obesity

Interventions

Diet; Exercise; Bariatric Surgery

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Sankar Navaneethan, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (1)