Status:
COMPLETED
Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes
Lead Sponsor:
Duke University
Collaborating Sponsors:
deCODE genetics
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
NA
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 assessm...
Detailed Description
One thousand outpatients will be enrolled over two years at two university-affiliated primary care clinics. Patients will be assigned to one of three study arms: those who want genetic testing for dia...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00849563
Start Date
April 1 2009
End Date
June 1 2013
Last Update
April 10 2014
Active Locations (2)
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1
Duke Family Medicine at Pickens
Durham, North Carolina, United States, 27705
2
Duke Health Center at Pickett Rd
Durham, North Carolina, United States, 27705