Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes
TDE
1 other identifier
interventional
450
1 country
2
Brief 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.
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-type-2
Started Apr 2009
Longer than P75 for not_applicable diabetes-mellitus-type-2
2 active sites
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
February 22, 2009
CompletedFirst Posted
Study publicly available on registry
February 24, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedApril 10, 2014
April 1, 2014
2.4 years
February 22, 2009
April 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of weight loss
12 months
Secondary Outcomes (2)
Change in perceptions of personal risk for Type 2 diabetes
12 months
Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR)
12 months
Study Arms (3)
SRA+genetic test
ACTIVE COMPARATORpatients randomized to receive genetic test for type 2 diabetes risk will be followed and surveyed and will be counseled based on SAR and genetic risk for type 2 diabetes
SRA only
NO INTERVENTIONPatients randomized to not get genetic testing will be followed and surveyed and will be counseled based on SRA only
no testing control
NO INTERVENTIONPatients not interested in genetic testing will be followed and surveyed. Counseling will be based on SRA only
Interventions
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.
Eligibility Criteria
You may qualify if:
- Are male or female outpatients
- No self-reported history of diabetes
- No self-reported history of prior genetic testing for diabetes
- Not pregnant (self report)
- Are ≥18 and \<81 years of age
- Scheduled to receive serum glucose test in participating clinic
- Fasting at time of blood draw (no food or drink - except water - previous 8 hours: self report)
- Able and willing to give legally effective consent
- Able and willing to participate in patient questionnaires
- Ambulatory
You may not qualify if:
- Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening
- Self-report of current or prior diabetes diagnosis
- Self-reported prior history of genetic testing for diabetes
- Baseline serum glucose test result \>125
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- deCODE geneticscollaborator
Study Sites (2)
Duke Family Medicine at Pickens
Durham, North Carolina, 27705, United States
Duke Health Center at Pickett Rd
Durham, North Carolina, 27705, United States
Related Publications (2)
Waxler 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: 22302620DERIVEDCho AH, Killeya-Jones LA, O'Daniel JM, Kawamoto K, Gallagher P, Haga S, Lucas JE, Trujillo GM, Joy SV, Ginsburg GS. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design. BMC Health Serv Res. 2012 Jan 18;12:16. doi: 10.1186/1472-6963-12-16.
PMID: 22257365DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey Ginsburg, Md, PhD
Institute for Genome Sciences and Policy, Duke University
- PRINCIPAL INVESTIGATOR
Alex Cho, MD
Institute for Genome Sciences and Policy, Duke University
- PRINCIPAL INVESTIGATOR
Scott Joy, MD
Duke University
- PRINCIPAL INVESTIGATOR
Susanne Haga, PhD
Institute for Genome Sciences and Policy, Duke University
- PRINCIPAL INVESTIGATOR
Isaac Lipkus, PhD
Institute for Genome Sciences and Policy, Duke University
- PRINCIPAL INVESTIGATOR
Gloria Trujillo, MD
Duke University
- PRINCIPAL INVESTIGATOR
Julianne O'Daniel, PhD
Institute for Genome Sciences and Policy, Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2009
First Posted
February 24, 2009
Study Start
April 1, 2009
Primary Completion
September 1, 2011
Study Completion
June 1, 2013
Last Updated
April 10, 2014
Record last verified: 2014-04