Interaction of Potassium and Genetic Risk Variants on Diabetes Risk

December 7, 2017 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

11812

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Member of the Atherosclerosis Risk in Communities (ARIC) Study or Jackson Heart Study (JHS) cohorts

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ARIC and JHS participants
A combined cohort of Atherosclerosis Risk in Communities (ARIC) Study and Jackson Heart Study (JHS) participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, mean of 8 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Johns Hopkins University
University of Colorado, Denver
University of Mississippi Medical Center

Investigators

  • Principal Investigator: Ranee Chatterjee, MD, MPH, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

December 8, 2017

Last Update Submitted That Met QC Criteria

December 7, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00065581

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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