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CRIC-Visceral Adiposity and Physical Fitness in Chronic Kidney Disease

Information source: The Cleveland Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Insufficiency, Chronic; Obesity

Phase: N/A

Status: Recruiting

Sponsored by: The Cleveland Clinic

Official(s) and/or principal investigator(s):
Sankar Navaneethan, M.D., Principal Investigator, Affiliation: The Cleveland Clinic

Overall contact:
Sankar Navaneethan, M.D., Phone: 216-636-9230, Email: navanes@ccf.org

Summary

Obesity and chronic kidney disease (CKD) are major public health problems. In contrary to observations in general population, higher body mass index in those with pre-existing CKD is associated with lower mortality. Chronic Renal Insufficiency Cohort (CRIC) is an ongoing observational study to examine the consequences of CKD with a particular focus on cardiovascular illness like myocardial infarction (heart attack) and stroke. Among CRIC study participants, the investigators propose to obtain visceral and subcutaneous adiposity and physical fitness measures and study its associations with patient-centered outcomes. This study will help the investigators understand the independent and combined effects of visceral adiposity and physical fitness on cardiovascular disease, renal disease progression and death among those with CKD. Further, it will identify mechanisms that could be targeted to reduce the detrimental effects of visceral adiposity in those with kidney disease.

Clinical Details

Official title: Visceral Adiposity and Physical Fitness in CKD

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Composite of mortality, cardiovascular events, End Stage Renal Disease (ESRD) and 50% decline in estimated glomerular filtration rate (eGFR)

Secondary outcome:

All-cause death

Cardiovascular events (acute myocardial infarction, congestive heart failure, cardiac arrhythmias, peripheral vascular disease and cerebrovascular events)

Renal events - End Stage Renal Disease plus 50% decline in Glomerular filtration rate (GFR)

Detailed description: Obesity and chronic kidney disease (CKD) are major public health problems. Obesity independent of its relationship with diabetes and hypertension is associated with the development and progression of kidney disease. However, higher body mass index (BMI) in those with pre-existing CKD is associated with lower mortality (obesity paradox). This may be due to the inability of BMI to differentiate fat mass and muscle mass, which may have opposite relationship with cardiovascular disease and death. Body fat distribution is a major factor of metabolic health with metabolic abnormalities correlating better with visceral than subcutaneous adipose tissue. Further, higher fitness levels among those with higher BMI is associated with a lower prevalence of cardiovascular risk factors and mortality that might explain this obesity paradox. Therefore, among Chronic Renal Insufficiency Cohort (CRIC) study participants, the investigators propose (a) to examine whether visceral adiposity is associated with a higher incidence of composite outcomes (i. e., mortality, cardiovascular events, end stage renal disease, and 50% decline in estimated glomerular filtration rate), (b) to determine if physical fitness modifies the association between adiposity and outcomes, and (c) to study whether visceral adiposity and physical fitness are associated with altered adipokine profile, inflammation, insulin resistance, and oxidative stress. The study proposes to enroll 526 patients with varying degrees of kidney disease from 7 clinical centers involved in the CRIC study. Visceral adiposity will be measured by magnetic resonance imaging (MRI) of the abdomen using a standard protocol, and physical fitness will be measured using a 400 m walk test during routine CRIC study visits. Results from this study will help the Investigators understand the independent and combined effects of visceral adiposity and physical fitness on cardiovascular disease and kidney disease progression among CKD patients. This study will also highlight potential pathways that mediate the relationship between adiposity and outcomes, which will become the focus of future therapeutic investigations in CKD.

Eligibility

Minimum age: 21 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Current participant in Chronic Renal Insufficiency Cohort Study (CRIC)

- Age 21-79

- Estimated Glomerular Filtration Rate 25-74 ml/min/1. 73m^2

Exclusion Criteria:

- Pacemaker

- Metallic prosthesis or foreign body (joints, heart valves, stents, clips)

- Severe claustrophobia

- Severe osteoarthritis (use of walker or other assisted devices) and peripheral

vascular disease

- Recent cardiovascular or cerebrovascular events (within 6 months prior to enrollment)

Locations and Contacts

Sankar Navaneethan, M.D., Phone: 216-636-9230, Email: navanes@ccf.org

University of Illinois at Chicago, Chicago, Illinois 60612, United States; Not yet recruiting
Janet Cohan, MSN, Phone: 312-996-6033, Email: jcohan@uic.edu
James P Lash, MD, Principal Investigator

University of Maryland Medical System, Baltimore, Maryland 21201, United States; Recruiting
Wanda Fink, RN, Phone: 410-706-6559, Email: wfink@medicine.umaryland.edu
Jeffrey Fink, MD, Principal Investigator

University of Michigan, Ann Arbor, Michigan 48109, United States; Recruiting
Denise Cornish-Zirker, BSN, Phone: 734-998-7947, Email: cricstudy@med.umich.edu
Akinlolu Ojo, MD, PhD, Principal Investigator

Case Western Reserve University, Cleveland, Ohio 44106, United States; Recruiting
Louise Strauss, RN, Phone: 216-844-1285, Email: Louise.Strauss@UHhospitals.org
Mahboob Rahman, MD, Principal Investigator

Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Andrea Aaby, MPH, Phone: 216-444-1152, Email: aabya@ccf.org
Annette Russo, Phone: 216-444-2266, Email: RUSSOA@ccf.org
Sankar Navaneethan, MD, Principal Investigator
John Kirwan, Ph.D, Sub-Investigator
Eric Remer, MD, Sub-Investigator
Erika Schneider, Ph.D, Sub-Investigator

Metro Health Medical Center, Cleveland, Ohio 44109, United States; Recruiting
Ann Slaven, Phone: 216-778-1849, Email: aslaven@metrohealth.org
Jeffrey Schelling, MD, Principal Investigator

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Not yet recruiting
Angie Sheridan, MPH, Phone: 215-349-8002, Email: angsher@mail.med.upenn.edu
Raymond Townsend, MD, Principal Investigator

University of Pennsylvania Scientific & Data Coordinating Center, Philadelphia, Pennsylvania 19104, United States; Active, not recruiting

Additional Information

Starting date: April 2015
Last updated: July 14, 2015

Page last updated: August 23, 2015

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