DiabetesNCT03367455
Interaction of Potassium and Genetic Risk Variants on Diabetes Risk
An observational study of Diabetes, run by Duke University.
Trial summary
The investigators propose to study the association of the KCNJ11 (Potassium Voltage-Gated Channel Subfamily J Member 11) polymorphisms on diabetes risk in the Atherosclerosis Risk in Communities (ARIC) and Jackson Heart Study (JHS) cohorts. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 11,812 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Nov 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The ARIC study is a prospective cohort of 15,792 adults between the ages of 45 and 64 years at the baseline visit. Participants were recruited from four communities in the US-Forsyth County, North Carolina, Jackson, Mississippi, Minneapolis, Minnesota, and Washington County, Maryland. All participants attended an initial baseline visit between 1987-1989. JHS is a community-based, prospective cohort study of 5301 African-American adults, aged 21-95 years at the baseline visit, from the Jackson, Mississippi metropolitan area. Participants had baseline data collected between 2000 and 2004.
Who may be able to join
- Member of the Atherosclerosis Risk in Communities (ARIC) Study or Jackson Heart Study (JHS) cohorts
Who cannot join
- Had not fasted 8 or more hours for the baseline visit
- Prevalent diabetes at baseline exam
- Missing information on serum potassium
- Missing single nucleotide polymorphism (SNP) data
- Evidence of kidney dysfunction
- Race other than black/African American or white/Caucasian
- Missing other covariates
About this study
Official title: Interaction of Potassium Measures With Potassium Channel Genetic Variants on Diabetes Risk: The Atherosclerosis Risk in Communities (ARIC) Study and Jackson Heart Study (JHS)
The investigators propose to study the association of the KCNJ11 (Potassium Voltage-Gated Channel Subfamily J Member 11) polymorphisms on diabetes risk in the Atherosclerosis Risk in Communities (ARIC) and Jackson Heart Study (JHS) cohorts. The investigators also propose to test for an interaction between serum K and these genetic variants. By testing for such an interaction, it will be determined if, among participants with these genetic variants, a low-normal serum K was a stronger predictor of diabetes risk compared to those participants without these genetic variants.
- Conditions
- Diabetes
- Keywords
- Potassium, Genetic Variants
- Medical subject headings
- Diabetes Mellitus
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 |
|---|---|---|
| ARIC and JHS participants | A combined cohort of Atherosclerosis Risk in Communities (ARIC) Study and Jackson Heart Study (JHS) participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations of serum potassium and KCNJ11 variants with incident diabetes as represented by odds ratio
Calculation of odds ratio will be used to represent the risk of incident diabetes associated with serum K, rs5215, and rs5219 within the cohort
Measured: through study completion, mean of 8 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study startMay 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Retrospective
- Enrolment
- 11,812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Colorado, Denver, University of Mississippi Medical Center
- Responsible party
- Sponsor
- Investigators
- Ranee Chatterjee, MD, MPH, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367455
- Sponsor's protocol ID
- Pro00065581
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Potassium Measures With Potassium Channel Genetic Variants on Diabetes Risk: The Atherosclerosis Risk in Communities (ARIC) Study and Jackson Heart Study (JHS)
- ClinicalTrials.gov ID
- NCT03367455
- Acronym / sponsor ID
- Pro00065581
- Conditions
- Diabetes
- Keywords
- Potassium, Genetic Variants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,812 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of Colorado, Denver, University of Mississippi Medical Center
- Study start
- May 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 8 Dec 2017 (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.
The investigators propose to study the association of the KCNJ11 (Potassium Voltage-Gated Channel Subfamily J Member 11) polymorphisms on diabetes risk in the Atherosclerosis Risk in Communities (ARIC) and Jackson Heart Study (JHS) cohorts. The investigators also propose to test for an interaction between serum K and these genetic variants. By testing for such an interaction, it will be determined if, among participants with these genetic variants, a low-normal serum K was a stronger predictor of diabetes risk compared to those participants without these genetic variants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARIC and JHS participants | – | –A combined cohort of Atherosclerosis Risk in Communities (ARIC) Study and Jackson Heart Study (JHS) participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The ARIC study is a prospective cohort of 15,792 adults between the ages of 45 and 64 years at the baseline visit. Participants were recruited from four communities in the US-Forsyth County, North Carolina, Jackson, Mississippi, Minneapolis, Minnesota, and Washington County, Maryland. All participants attended an initial baseline visit between 1987-1989. JHS is a community-based, prospective cohort study of 5301 African-American adults, aged 21-95 years at the baseline visit, from the Jackson, Mississippi metropolitan area. Participants had baseline data collected between 2000 and 2004.
Key inclusion criteria (1 listed)
- Member of the Atherosclerosis Risk in Communities (ARIC) Study or Jackson Heart Study (JHS) cohorts
Key exclusion criteria (7 listed)
- Had not fasted 8 or more hours for the baseline visit
- Prevalent diabetes at baseline exam
- Missing information on serum potassium
- Missing single nucleotide polymorphism (SNP) data
- Evidence of kidney dysfunction
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
Associations of serum potassium and KCNJ11 variants with incident diabetes as represented by odds ratio
Time frame: through study completion, mean of 8 years of follow-up
Calculation of odds ratio will be used to represent the risk of incident diabetes associated with serum K, rs5215, and rs5219 within the cohort
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 8 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Ranee Chatterjee, MD, MPH principal investigator
Duke Health
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Duke University.
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 7 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 8 Dec 2017. 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 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?
Associations of serum potassium and KCNJ11 variants with incident diabetes as represented by odds ratio (time frame: through study completion, mean of 8 years of follow-up). 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 8 Dec 2017.