An observational study in Diabetes Mellitus, Chronic Kidney Diseases and Heart Diseases, sponsored by University of New Mexico. Recruiting at 3 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by University of New Mexico · Observational
Despite many advances in our understanding of the natural history and progression of chronic kidney disease (CKD) and cardio vascular disease (CVD) in the parent CRIC study over the past 15 years, important questions about key risk factors for these diseases remain unanswered in the AI population. To address this burden of CKD in AI communities Investigators formed a consortium of investigators with extensive experience in conducting research of chronic diseases including diabetes, cardiovascular and kidney disease in AIs of Southwestern US. The proposed CRIC ancillary cohort study of 500 AIs (AI-CRIC) will rapidly improve our understanding of both potential risk factors for CKD progression, as well as the scope of this disease among AIs. This study leverages the current CRIC study and incorporates the planned activities of the next phase of the study - "CRIC 2018" - by implementing contemporary CRIC protocols for kidney and cardiovascular measurement and outcomes.
Investigators will conduct a longitudinal study of a CKD cohort of Southwest AIs to identify unique risk factors for CKD and CVD progression and compare CKD and CVD event rates and risk factors between AI and the populations represented in CRIC. Investigators will establish a specimen bank to support future ancillary studies designed to identify and examine biomarkers associated with the progression of CKD in AIs.
At the Clinic Visit the following will occur:
This visit takes about 1 to 2 hours. Participants will be contacted by telephone six months after the Baseline Visit to ask about recent medical events and medications.
Participants will be asked to return to the center for annual visits during which many but not all of the procedures described above will be conducted.
Additionally, participants will be asked to participate in one of two substudies using remote data collection techniques to identify trajectories of kidney function and cardiovascular risk sub-phenotypes
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's planned enrollment of 500 is above the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
American Indians at 3 sites.
Exclusion Criteria:
Slope of the GFR
Primary outcomes regarding Cardio vascular disease will focus on clinical events indicative of ischemic heart disease, CHF, stroke, and peripheral vascular disease supplemented by radiographic evidence of progressive CVD.
Time frame: 5 years
Onset of End Stage Renal Disease
The measure is reflected in decline of GFR levels
Time frame: 5 years
Significant loss of renal function
The measure is reflected in decline of GFR levels
Time frame: 5 years
Composite clinical outcome defined by the occurrence of either 50% decline, or 25 l/min/1.73 m2 decline in GFR from baseline, or onset of ESRD
The composite clinical outcome includes onset of End Stage Renal Disease, Significant loss of renal function or changes in proteinuria over time from baseline
Time frame: 5 years
Slope of change in proteinuria over time
The changes in the levels of proteinuria overtime
Time frame: 5 years
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University of New Mexico