Interaction of Potassium and Genetic Risk Variants on Dia... | NCT03367455

Studies
Interaction of Potassium and Genetic Risk Variants on Diabetes Risk

NCT03367455

Sponsor

Duke University

Status

Completed

Last Update Posted

Dec 8, 2017Actual

Enrollment

11,812Actual

Phase

Not provided

Conditions

Diabetes

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Nov 2017Actual

Completion Date

Nov 2017Actual

First Submitted Date

Dec 4, 2017

First Submission Date that Met QC Criteria

Dec 7, 2017

First Posted Date

Dec 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2017

Last Update Posted Date

Dec 8, 2017Actual

Name	Class
Johns Hopkins University	OTHER
University of Colorado, Denver	OTHER
University of Mississippi Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11,812Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARIC and JHS participants		A combined cohort of Atherosclerosis Risk in Communities (ARIC) Study and Jackson Heart Study (JHS) participants

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Ranee Chatterjee, MD, MPH	Duke Health	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided