Interaction of Potassium and Genetic Risk Variants on Diabetes Risk

NCT03367455 | Completed

• 1 other identifier: Pro00065581
• Study Type: observational
• Target: 11,812
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes

Keywords

Potassium; Genetic Variants

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, mean of 8 years of follow-up

Study Arms (1)

ARIC and JHS participants

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Johns Hopkins University: collaborator
• University of Colorado, Denver: collaborator
• University of Mississippi Medical Center: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ranee Chatterjee, MD, MPH

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: May 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share