Renal Insufficiency, ChronicCRIC-VAPNCT02405650
CRIC-Visceral Adiposity and Physical Fitness in Chronic Kidney Disease
An observational study of Renal Insufficiency, Chronic and Obesity, run by Baylor College of Medicine at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Renal Insufficiency, Chronic, Obesity
- How many people
- 453 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2015to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Must be participant in Prospective Cohort Study of Chronic Renal Insufficiency (CRIC). CRIC participants are a racially and ethnically diverse group of adult patients with mild-to-moderate CRI.
Who may be able to join
- Age 21-79
- Estimated Glomerular Filtration Rate 20-74 ml/min/1.73m^2
Who cannot join
- 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).
Show all 10Show fewer
- Recent cardiovascular or cerebrovascular events (within 6 months prior to enrollment)
- Kidney transplant
- Currently on dialysis
- Peripheral vascular disease limiting long distance walking
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Maryland Medical System
Baltimore, Maryland, 21201
Johns Hopkins University - ProHealth
Baltimore, Maryland, 21207
University of Illinois at Chicago
Chicago, Illinois, 60612
Case Western Reserve University
Cleveland, Ohio, 44106
Metro Health Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 77030
University of Pennsylvania Scientific & Data Coordinating Center
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Insufficiency, Chronic, Obesity
- Keywords
- CKD, chronic kidney disease, CRIC
- Medical subject headings
- Renal Insufficiency, Chronic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRIC VAP cohort | If eligible, the participant will have additional testing at regular annual CRIC Visit. The following will occur: * abdominal and pelvic Magnetic Resonance Imaging (MRI) scan * 400 meter walk test for physical fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
All-cause death
Death details are obtained from linkage of the CRIC study with the National Death Index.
Measured: 5 years
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
Measured: end of the study
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Case Western Reserve University, University of Michigan, University of Illinois Chicago, University of Maryland, MetroHealth Medical Center, The Cleveland Clinic, Johns Hopkins University
- Responsible party
- Principal investigator, Sankar Navaneethan, Baylor College of Medicine
- Investigators
- Sankar Navaneethan, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405650
- Sponsor's protocol ID
- 37396 CRIC VAP
- Acronym
- CRIC-VAP
- Status last verified
- Jul 2019
- First submitted
- 25 Mar 2015
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Adiposity and Physical Fitness in CKD
- ClinicalTrials.gov ID
- NCT02405650
- Acronym / sponsor ID
- CRIC-VAP / 37396 CRIC VAP
- Conditions
- Renal Insufficiency, Chronic, Obesity
- Keywords
- CKD, chronic kidney disease, CRIC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Case Western Reserve University, University of Michigan, University of Illinois Chicago, University of Maryland, MetroHealth Medical Center, The Cleveland Clinic, Johns Hopkins University
- Study start
- Apr 2015
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRIC VAP cohort | – | –If eligible, the participant will have additional testing at regular annual CRIC Visit. The following will occur: * abdominal and pelvic Magnetic Resonance Imaging (MRI) scan * 400 meter walk test for physical fitness |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Must be participant in Prospective Cohort Study of Chronic Renal Insufficiency (CRIC). CRIC participants are a racially and ethnically diverse group of adult patients with mild-to-moderate CRI.
Key inclusion criteria (2 listed)
- Age 21-79
- Estimated Glomerular Filtration Rate 20-74 ml/min/1.73m^2
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of mortality, cardiovascular events, End Stage Renal Disease (ESRD) and 50% decline in estimated glomerular filtration rate (eGFR)
Time frame: 5 years
Since visceral adiposity is related to both cardiovascular disease and kidney function and to adequately power the study, we chose the composite end-point.
3 secondary outcomes
All-cause death
Time frame: 5 years
Cardiovascular events (acute myocardial infarction, congestive heart failure, cardiac arrhythmias, peripheral vascular disease and cerebrovascular events)
Time frame: end of the study
Renal events - End Stage Renal Disease plus 50% decline in Glomerular filtration rate (GFR)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sankar Navaneethan, M.D. principal investigator
Baylor College of Medicine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, Chronic and Obesity, run by Baylor College of Medicine at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of mortality, cardiovascular events, End Stage Renal Disease (ESRD) and 50% decline in estimated glomerular filtration rate (eGFR) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.