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Interaction of Potassium and Genetic Risk Variants on Diabetes Risk

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. Read our disclaimer for details. Identifier: NCT03367455
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Johns Hopkins University
University of Colorado, Denver
University of Mississippi Medical Center
Information provided by (Responsible Party):
Duke University

Brief 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. 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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 11812 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Actual Study Start Date : May 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

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 identifier (NCT number): NCT03367455

Sponsors and Collaborators
Duke University
Johns Hopkins University
University of Colorado, Denver
University of Mississippi Medical Center
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Principal Investigator: Ranee Chatterjee, MD, MPH Duke University Health System

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Responsible Party: Duke University Identifier: NCT03367455     History of Changes
Other Study ID Numbers: Pro00065581
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Genetic Variants
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases