CRIC-Visceral Adiposity and Physical Fitness in Chronic Kidney Disease

Obesity Clinical Trial

— CRIC-VAP  

Official title:

Visceral Adiposity and Physical Fitness in CKD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405650
• Other study ID #: 37396 CRIC VAP
• Status: Completed
• Start date: April 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: July 2019
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Obesity
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University - ProHealth	Baltimore	Maryland
United States	University of Maryland Medical System	Baltimore	Maryland
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Metro Health Medical Center	Cleveland	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pennsylvania Scientific & Data Coordinating Center	Philadelphia	Pennsylvania

Sponsors (9)

Lead Sponsor	Collaborator
Baylor College of Medicine	Case Western Reserve University, Johns Hopkins University, MetroHealth Medical Center, The Cleveland Clinic, University of Illinois at Chicago, University of Maryland, University of Michigan, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of mortality, cardiovascular events, End Stage Renal Disease (ESRD) and 50% decline in estimated glomerular filtration rate (eGFR)	Since visceral adiposity is related to both cardiovascular disease and kidney function and to adequately power the study, we chose the composite end-point.	5 years
Secondary	All-cause death	Death details are obtained from linkage of the CRIC study with the National Death Index.	5 years
Secondary	Cardiovascular events (acute myocardial infarction, congestive heart failure, cardiac arrhythmias, peripheral vascular disease and cerebrovascular events)	Once a patient reports a clinical event or hospitalization during the study visit, de-identified charts are adjudicated by review of hospital records by two physician reviewers and linkage with other national database	end of the study
Secondary	Renal events - End Stage Renal Disease plus 50% decline in Glomerular filtration rate (GFR)	Incident End Stage Renal Disease is being defined as initiation of chronic dialysis or kidney transplantation	5 years