In this R21 proposal, we address the hypothesis that knowledge of increased individual diabetes genetic risk will motivate patients with pre-diabetes to adopt and adhere to preventive lifestyle changes. Moreover, because genetic testing will also identify people with average or decreased relative risk, we will also examine the impact of """"""""Lower Risk"""""""" testing results. We will adapt and extend existing multi- factorial genetic risk counseling approaches to the unique clinical problem of conveying complex disease genetic risk by creating a diabetes genetic risk counseling intervention. This intervention will be based on each subject's diabetes genotype risk score - a single aggregate score our team has developed that incorporates 18 currently identified diabetes risk genetic loci. To rigorously test the marginal impact of diabetes genotype testing compared to usual care, we will conduct a controlled trial among patients with pre-diabetes enrolled in a 12-session group-based lifestyle modification program for diabetes prevention.
The specific aims of this proposal are to examine differences in perceived diabetes risk, diet- and exercise-specific motivation, and program attendance comparing subjects receiving an individual genotype risk counseling intervention to similar patients receiving usual care (controls). Preliminary results from this R21 and experience developing the genotype risk counseling intervention will be applied to the design of a subsequent larger-scale intervention evaluating the impact of diabetes genotype testing on clinical outcomes such as weight loss and diabetes prevention.

Public Health Relevance

The clinical practice of medicine is changing rapidly in this """"""""dawn of the genomic era"""""""". With direct-to- consumer advertising by commercial companies and the eagerness with which many clinicians embrace new technology, it is imperative to establish the evidence base to guide the clinical application of genetic testing for common complex diseases such as type 2 diabetes. This R21 proposal will examine the impact on attitudes and behaviors in patients with pre-diabetes who are provided with their individual diabetes genotype risk score-a single score derived from aggregating the combined results of 18 diabetes risk-associated genetic loci.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21DK084527-01
Application #
7742390
Study Section
Special Emphasis Panel (ZDK1-GRB-G (M2))
Program Officer
Kimmel, Paul
Project Start
2009-09-30
Project End
2011-07-31
Budget Start
2009-09-30
Budget End
2010-07-31
Support Year
1
Fiscal Year
2009
Total Cost
$442,083
Indirect Cost
Name
Massachusetts General Hospital
Department
Type
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code
02199
Vassy, Jason L; He, Wei; Florez, Jose C et al. (2018) Six-Year Diabetes Incidence After Genetic Risk Testing and Counseling: A Randomized Clinical Trial. Diabetes Care 41:e25-e26
Grant, Richard W; O'Brien, Kelsey E; Waxler, Jessica L et al. (2013) Personalized genetic risk counseling to motivate diabetes prevention: a randomized trial. Diabetes Care 36:13-9
Vassy, Jason L; Donelan, Karen; Hivert, Marie-France et al. (2013) Genetic susceptibility testing for chronic disease and intention for behavior change in healthy young adults. J Community Genet 4:263-71
Grant, Richard W; Wexler, Deborah J (2012) Personalized medicine in Type 2 diabetes: what does the future hold? Diabetes Manag (Lond) 2:199-204
Vassy, Jason L; O'Brien, Kelsey E; Waxler, Jessica L et al. (2012) Impact of literacy and numeracy on motivation for behavior change after diabetes genetic risk testing. Med Decis Making 32:606-15
Waxler, Jessica L; O'Brien, Kelsey E; Delahanty, Linda M et al. (2012) Genetic counseling as a tool for type 2 diabetes prevention: a genetic counseling framework for common polygenetic disorders. J Genet Couns 21:684-91
de Miguel-Yanes, Jose M; Shrader, Peter; Pencina, Michael J et al. (2011) Genetic risk reclassification for type 2 diabetes by age below or above 50 years using 40 type 2 diabetes risk single nucleotide polymorphisms. Diabetes Care 34:121-5
Grant, Richard W; Meigs, James B; Florez, Jose C et al. (2011) Design of a randomized trial of diabetes genetic risk testing to motivate behavior change: the Genetic Counseling/lifestyle Change (GC/LC) Study for Diabetes Prevention. Clin Trials 8:609-15
Markowitz, Sarah M; Park, Elyse R; Delahanty, Linda M et al. (2011) Perceived impact of diabetes genetic risk testing among patients at high phenotypic risk for type 2 diabetes. Diabetes Care 34:568-73
Grant, Richard W; Wexler, Deborah J (2010) Loss-of-function CYP2C9 variants: finding the correct clinical role for Type 2 diabetes pharmacogenetic testing. Expert Rev Cardiovasc Ther 8:339-43

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