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Chronic Kidney Disease and Cardiovascular Disease Risk Assessment

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ClinicalTrials.gov Identifier: NCT03975439
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Mark D. Baldwin, Pacific Northwest University of Health Sciences

Brief Summary:
This study will investigate chronic kidney disease (CKD) and cardiovascular disease (CVD) risk factors in a sample population of Hispanics/Latinos and Caucasians in Yakima county that are rural dwelling. This investigation is intended to provide information on the impact rural geographical location and social determinants of health (SDOH) have on CKD and CVD risk factors.

Condition or disease Intervention/treatment
Chronic Kidney Diseases Diabetes Mellitus Hypertension Diagnostic Test: Hemoglobin A1C Diagnostic Test: Urinalysis Diagnostic Test: Whole blood creatinine level

Detailed Description:

Yakima County has a large hispanic farmworker population. The peak work times are between May and September. There is a growing body of research that shows the risk of agricultural workers in work environments with extreme heat.

The purpose of this pilot study is to look at incidence of non-diagnosed chronic kidney disease within Yakima County to inform future studies to examine other factors and unique bio-markers that may help in the early diagnosis of heat related injuries in agricultural workers.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Chronic Kidney Disease and Cardiovascular Disease Risk Assessment in Yakima County
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases


Intervention Details:
  • Diagnostic Test: Hemoglobin A1C
    Finger stick hemoglobin A1C
  • Diagnostic Test: Urinalysis
    Urinalysis by dip stick looking for urine protein level
  • Diagnostic Test: Whole blood creatinine level
    Finger stick looking for serum creatinine as an estimate of renal function


Primary Outcome Measures :
  1. Incidence of undiagnosed chronic kidney disease in farmworkers in Yakima County, WA [ Time Frame: At the time of screening ]
    Finger stick and urinalysis will be done at the time of screening


Secondary Outcome Measures :
  1. Incidence of undiagnosed diabetes mellitus in farmworkers in Yakima County, WA [ Time Frame: At the time of screening ]
    Finger stick will be done at the time of screening

  2. Incidence of undiagnosed hypertension in farmworkers in Yakima, County, WA [ Time Frame: At the time of screening ]
    Measurement of blood pressure



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All adults of between the ages of 18 and 75 who do not meet the exclusion criteria and wish to undergo screening for kidney disease and diabetes.
Criteria

Inclusion Criteria:

  • Between the ages of 18 and 75

Exclusion Criteria:

  • Active malignancy
  • Currently pregnant
  • End stage renal disease requiring dialysis
  • Current active treatment for diabetes mellitus
  • Current care by a nephrologist for chronic kidney disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975439


Contacts
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Contact: Mark D Baldwin, DO 509-249-7749 mbaldwin@pnwu.edu
Contact: Gina Many, PhD 509-307-3709 gmany@pnwu.edu

Sponsors and Collaborators
Pacific Northwest University of Health Sciences
Investigators
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Principal Investigator: Mark D Baldwin, DO Pacific Northwest University of Health Science

Publications:

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Responsible Party: Mark D. Baldwin, Principal Investigator, Pacific Northwest University of Health Sciences
ClinicalTrials.gov Identifier: NCT03975439     History of Changes
Other Study ID Numbers: 2019-004
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency