CRIC-Visceral Adiposity and Physical Fitness in Chronic Kidney Disease



Status:Active, not recruiting
Conditions:Obesity Weight Loss, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:21 - 79
Updated:1/18/2019
Start Date:April 2015
End Date:July 2020

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Visceral Adiposity and Physical Fitness in CKD

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.

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.

Inclusion Criteria:

- Age 21-79

- Estimated Glomerular Filtration Rate 20-74 ml/min/1.73m^2

Exclusion Criteria:

- Pacemaker

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

*Sites may include patients with cardiac stents and/or dental implants based on the
local Radiology department criteria i.e. if there are no restrictions, they can
include patients with stents and/or dental implants. If the Radiology department
mandates the type of stent details and/or dental implants, site coordinator should
provide this to the local Radiology department and obtain permission before enrolling
the subject.

- Severe claustrophobia

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

*Sites may include patients with cane (single or quad).

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

- Kidney transplant

- Currently on dialysis

- Peripheral vascular disease limiting long distance walking
We found this trial at
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Cleveland, Ohio 44109
Principal Investigator: Edward Horwitz, MD
Phone: 216-778-1849
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Jonathan Taliercio, MD
Phone: 216-444-1152
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Panduranga Rao, MD
Phone: 734-998-7975
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Baltimore, Maryland 21201
Principal Investigator: Jeffrey Fink, MD
Phone: 410-706-6559
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Baltimore, Maryland 21207
Principal Investigator: Tariq Shafi, MBBS, MHS
Phone: 410-955-4156
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: James P Lash, MD
Phone: 312-996-6033
University of Illinois at Chicago A major research university in the heart of one of...
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Mahboob Rahman, MD
Phone: 216-844-1285
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Philadelphia, PA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Raymond Townsend, MD
Phone: 215-349-8002
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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