Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes

Summary

The primary objective of the study is to assess the clinical utility of a genetic test for Type 2 diabetes risk in combination with standardized risk assessment compared with standardized risk assessment alone, and to measure whether changes in perceived risk following genetic testing for Type 2 diabetes risk are correlated with behavior change and increased concern about risk for Type 2 diabetes.

Conditions

• Diabetes Mellitus, Type 2

Interventions

OTHER

Standardized Risk Assessment

patients interested in genetic testing will be randomly assigned to either get testing for type 2 diabetes or not. All arms with receive standardized risk asessements. This study is evaluating behavior after receipt of genetic risk information and different types of counseling.

Sponsors & Collaborators

• deCODE genetics

  collaborator INDUSTRY

• Duke University

  lead OTHER

Principal Investigators

• Geoffrey Ginsburg, Md, PhD · Institute for Genome Sciences and Policy, Duke University

• Alex Cho, MD · Institute for Genome Sciences and Policy, Duke University

• Scott Joy, MD · Duke University

• Susanne Haga, PhD · Institute for Genome Sciences and Policy, Duke University

• Isaac Lipkus, PhD · Institute for Genome Sciences and Policy, Duke University

• Gloria Trujillo, MD · Duke University

• Julianne O'Daniel, PhD · Institute for Genome Sciences and Policy, Duke University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2011-09-30

Completion

2013-06-30

Countries

• United States

Study Locations