Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Kidney Disease and Cardiovascular Disease Risk Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 4, 2019
First Posted Date June 5, 2019
Last Update Posted Date June 5, 2019
Estimated Study Start Date July 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 4, 2019)
  • 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
  • Incidence of undiagnosed hypertension in farmworkers in Yakima, County, WA [ Time Frame: At the time of screening ]
    Measurement of blood pressure
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Kidney Disease and Cardiovascular Disease Risk Assessment
Official Title Chronic Kidney Disease and Cardiovascular Disease Risk Assessment in Yakima County
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.
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.

Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Chronic Kidney Diseases
  • Diabetes Mellitus
  • Hypertension
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 4, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mark D Baldwin, DO 509-249-7749 mbaldwin@pnwu.edu
Contact: Gina Many, PhD 509-307-3709 gmany@pnwu.edu
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03975439
Other Study ID Numbers 2019-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mark D. Baldwin, Pacific Northwest University of Health Sciences
Study Sponsor Pacific Northwest University of Health Sciences
Collaborators Not Provided
Investigators
Principal Investigator: Mark D Baldwin, DO Pacific Northwest University of Health Science
PRS Account Pacific Northwest University of Health Sciences
Verification Date June 2019