Genetic Testing for Type 2 Diabetes
The Impact of Genetic Testing for Type 2 Diabetes on Health Behaviors
1 other identifier
interventional
601
1 country
1
Brief Summary
In this 6-month randomized, controlled trial, we examined whether providing participants with genetic test results and counseling regarding their risk for type 2 diabetes would motivate them to improve their health behaviors and lose weight to reduce their diabetes risk. We hypothesized that participants who received conventional diabetes counseling plus genetic test results and counseling would have at least 6 lb greater weight loss at 3 months than participants who received conventional diabetes counseling without genetic test results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Aug 2010
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
August 4, 2014
CompletedApril 24, 2015
April 1, 2014
2.6 years
January 29, 2010
April 16, 2014
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
weight 3 months post-enrollment
3 months
Secondary Outcomes (4)
Insulin Resistance (HOMA2-IR)
3 months
Perceived Lifetime Risk of Type 2 Diabetes
3 months
Daily Caloric Intake
3 months
Moderate Intensity Physical Activity
3 months
Study Arms (2)
CR+G
EXPERIMENTALconventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
CR+EYE
ACTIVE COMPARATORconventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
Interventions
Risk based on lifetime risk, fasting plasma glucose results, and family history.
addresses risk for age-related macular degeneration, glaucoma, cataracts
Eligibility Criteria
You may qualify if:
- body mass index \>27 kg/m2
- baseline fasting plasma glucose \<=125 mg/dL
You may not qualify if:
- prior diagnosis of type 2 diabetes
- fasting plasma glucose \>125 mg/dL on more than one occasion
- HbA1c \> 7%
- taking diabetes medication
- actively losing weight
- enrolled in research study focusing on lifestyle changes
- unable to provide informed consent or answer survey questions unassisted
- residing in nursing home or receiving home health care
- active diagnosis of psychosis or dementia
- at least one error on 6-item cognitive screener
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Department of Veterans Affairslead
- Duke Universitycollaborator
Study Sites (1)
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705, United States
Related Publications (4)
Vorderstrasse AA, Cho A, Voils CI, Orlando LA, Ginsburg GS. Clinical utility of genetic risk testing in primary care: the example of Type 2 diabetes. Per Med. 2013 Aug;10(6):549-563. doi: 10.2217/pme.13.47.
PMID: 29776196RESULTVoils CI, Coffman CJ, Edelman D, Maciejewski ML, Grubber JM, Sadeghpour A, Cho A, McKenzie J, Blanpain F, Scheuner M, Sandelowski M, Gallagher MP, Ginsburg GS, Yancy WS Jr. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:121. doi: 10.1186/1745-6215-13-121.
PMID: 22852560RESULTVoils CI, Coffman CJ, Grubber JM, Edelman D, Sadeghpour A, Maciejewski ML, Bolton J, Cho A, Ginsburg GS, Yancy WS Jr. Does Type 2 Diabetes Genetic Testing and Counseling Reduce Modifiable Risk Factors? A Randomized Controlled Trial of Veterans. J Gen Intern Med. 2015 Nov;30(11):1591-8. doi: 10.1007/s11606-015-3315-5. Epub 2015 Apr 16.
PMID: 25876740DERIVEDWaxler JL, O'Brien KE, Delahanty LM, Meigs JB, Florez JC, Park ER, Pober BR, Grant RW. Genetic counseling as a tool for type 2 diabetes prevention: a genetic counseling framework for common polygenetic disorders. J Genet Couns. 2012 Oct;21(5):684-91. doi: 10.1007/s10897-012-9486-x.
PMID: 22302620DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Corrine Voils, PhD
- Organization
- Durham VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Corrine I. Voils, PhD
Durham VA Medical Center, Durham, NC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2010
First Posted
February 2, 2010
Study Start
August 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 24, 2015
Results First Posted
August 4, 2014
Record last verified: 2014-04