Chronic Kidney DiseasesNCT03975439
Chronic Kidney Disease and Cardiovascular Disease Risk Assessment
An observational study of Chronic Kidney Diseases and Diabetes Mellitus, run by Pacific Northwest University of Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Diabetes Mellitus, Hypertension
- What is being tested?
- Hemoglobin A1C, Urinalysis and Whole blood creatinine level
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 5 Feb 2020
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Between the ages of 18 and 75
Who cannot join
- 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
About this study
Official title: Chronic Kidney Disease and Cardiovascular Disease Risk Assessment in Yakima County
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus, Hypertension
- Being tested
- Hemoglobin A1C, Urinalysis, Whole blood creatinine level
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoglobin A1CDiagnostic test
Finger stick hemoglobin A1C
UrinalysisDiagnostic test
Urinalysis by dip stick looking for urine protein level
Whole blood creatinine levelDiagnostic test
Finger stick looking for serum creatinine as an estimate of renal function
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of undiagnosed chronic kidney disease in farmworkers in Yakima County, WA
Finger stick and urinalysis will be done at the time of screening
Measured: At the time of screening
Secondary outcomes (2)
Incidence of undiagnosed diabetes mellitus in farmworkers in Yakima County, WA
Finger stick will be done at the time of screening
Measured: At the time of screening
Incidence of undiagnosed hypertension in farmworkers in Yakima, County, WA
Measurement of blood pressure
Measured: At the time of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Feb 2020
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Why it stopped: Decided to do smaller pilot study instead
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Northwest University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark D. Baldwin, Pacific Northwest University of Health Sciences
- Investigators
- Mark D Baldwin, DO, Principal investigator, Pacific Northwest University of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975439
- Sponsor's protocol ID
- 2019-004
- Status last verified
- Jul 2022
- First submitted
- 4 Jun 2019
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hebert JR, Braun KL, Kaholokula JK, Armstead CA, Burch JB, Thompson B. Considering the Role of Stress in Populations of High-Risk, Underserved Community Networks Program Centers. Prog Community Health Partnersh. 2015;9 Suppl(0):71-82. doi: 10.1353/cpr.2015.0028.
PubMed 26213406Coronado GD, Thompson B, Tejeda S, Godina R, Chen L. Sociodemographic factors and self-management practices related to type 2 diabetes among Hispanics and non-Hispanic whites in a rural setting. J Rural Health. 2007 Winter;23(1):49-54. doi: 10.1111/j.1748-0361.2006.00067.x.
PubMed 17300478Ferdinand KC, Weitzman R, Israel M, Lee J, Purkayastha D, Jaimes EA. Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2011 Mar-Apr;5(2):102-13. doi: 10.1016/j.jash.2011.01.006.
PubMed 21414565Kurpas D, Mroczek B, Bielska D. Rural and urban disparities in quality of life and health-related behaviors among chronically ill patients. Rural Remote Health. 2014;14(2):2485. Epub 2014 Jun 10.
PubMed 24916658Krishna S, Gillespie KN, McBride TM. Diabetes burden and access to preventive care in the rural United States. J Rural Health. 2010 Winter;26(1):3-11. doi: 10.1111/j.1748-0361.2009.00259.x.
PubMed 20105262Melvin CL, Corbie-Smith G, Kumanyika SK, Pratt CA, Nelson C, Walker ER, Ammerman A, Ayala GX, Best LG, Cherrington AL, Economos CD, Green LW, Harman J, Hooker SP, Murray DM, Perri MG, Ricketts TC; Workshop Working Group on CVD Prevention in High-Risk Rural Communities. Developing a research agenda for cardiovascular disease prevention in high-risk rural communities. Am J Public Health. 2013 Jun;103(6):1011-21. doi: 10.2105/AJPH.2012.300984. Epub 2013 Apr 18.
PubMed 23597371Shoham DA, Vupputuri S, Kaufman JS, Kshirsagar AV, Diez Roux AV, Coresh J, Heiss G. Kidney disease and the cumulative burden of life course socioeconomic conditions: the Atherosclerosis Risk in Communities (ARIC) study. Soc Sci Med. 2008 Oct;67(8):1311-20. doi: 10.1016/j.socscimed.2008.06.007. Epub 2008 Jul 28.
PubMed 18667261
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Kidney Disease and Cardiovascular Disease Risk Assessment in Yakima County
- ClinicalTrials.gov ID
- NCT03975439
- Acronym / sponsor ID
- 2019-004
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus, Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Decided to do smaller pilot study instead
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pacific Northwest University of Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 5 Jun 2019 (actual)
- 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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Between the ages of 18 and 75
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemoglobin A1CFinger stick hemoglobin A1C | Diagnostic test | – |
| UrinalysisUrinalysis by dip stick looking for urine protein level | Diagnostic test | – |
| Whole blood creatinine levelFinger stick looking for serum creatinine as an estimate of renal function | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Incidence of undiagnosed diabetes mellitus in farmworkers in Yakima County, WA
Time frame: At the time of screening
Incidence of undiagnosed hypertension in farmworkers in Yakima, County, WA
Time frame: At the time of screening
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Background: PubMed 26213406Hebert JR, Braun KL, Kaholokula JK, Armstead CA, Burch JB, Thompson B. Considering the Role of Stress in Populations of High-Risk, Underserved Community Networks Program Centers. Prog Community Health Partnersh. 2015;9 Suppl(0):71-82. doi: 10.1353/cpr.2015.0028.
- Background: PubMed 17300478Coronado GD, Thompson B, Tejeda S, Godina R, Chen L. Sociodemographic factors and self-management practices related to type 2 diabetes among Hispanics and non-Hispanic whites in a rural setting. J Rural Health. 2007 Winter;23(1):49-54. doi: 10.1111/j.1748-0361.2006.00067.x.
- Background: PubMed 21414565Ferdinand KC, Weitzman R, Israel M, Lee J, Purkayastha D, Jaimes EA. Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension. J Am Soc Hypertens. 2011 Mar-Apr;5(2):102-13. doi: 10.1016/j.jash.2011.01.006.
- Background: PubMed 24916658Kurpas D, Mroczek B, Bielska D. Rural and urban disparities in quality of life and health-related behaviors among chronically ill patients. Rural Remote Health. 2014;14(2):2485. Epub 2014 Jun 10.
- Background: PubMed 20105262Krishna S, Gillespie KN, McBride TM. Diabetes burden and access to preventive care in the rural United States. J Rural Health. 2010 Winter;26(1):3-11. doi: 10.1111/j.1748-0361.2009.00259.x.
- Background: PubMed 23597371Melvin CL, Corbie-Smith G, Kumanyika SK, Pratt CA, Nelson C, Walker ER, Ammerman A, Ayala GX, Best LG, Cherrington AL, Economos CD, Green LW, Harman J, Hooker SP, Murray DM, Perri MG, Ricketts TC; Workshop Working Group on CVD Prevention in High-Risk Rural Communities. Developing a research agenda for cardiovascular disease prevention in high-risk rural communities. Am J Public Health. 2013 Jun;103(6):1011-21. doi: 10.2105/AJPH.2012.300984. Epub 2013 Apr 18.
- Background: PubMed 18667261Shoham DA, Vupputuri S, Kaufman JS, Kshirsagar AV, Diez Roux AV, Coresh J, Heiss G. Kidney disease and the cumulative burden of life course socioeconomic conditions: the Atherosclerosis Risk in Communities (ARIC) study. Soc Sci Med. 2008 Oct;67(8):1311-20. doi: 10.1016/j.socscimed.2008.06.007. Epub 2008 Jul 28.
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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.
Mark D Baldwin, DO principal investigator
Pacific Northwest University of Health Science
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Diabetes Mellitus, run by Pacific Northwest University of Health Sciences.
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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of undiagnosed chronic kidney disease in farmworkers in Yakima County, WA (time frame: At the time of screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975439, which also lists 7 linked publications.
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 14 Jul 2022.