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| Name | Class |
|---|---|
| deCODE genetics | INDUSTRY |
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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.
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 diabetes risk will be randomly assigned to either receive the testing in addition to the SRA (SRA+G) or to receive the SRA only (SRA-only). Those who do not wish to have genetic testing will receive the SRA only. All patients will be surveyed at baseline, immediately after going through the SRA (risk-counseling visit; 2-4 weeks after initial visit), at 3 months post risk counseling visit and at 12 months post risk counseling visit. BMI, waist circumference, fasting plasma glucose and insulin will be measured at baseline and 12 months. Surveys will allow us to track patients' emotional responses to diabetes risk information and changing perceptions of personal risk for Type 2 diabetes over time, and to see if these correlate with subsequent diet and exercise behaviors.
We will use a linear model to assess the effects of genetic testing among the three study groups, using HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR) and weight loss as the primary outcomes. We will use generalized linear ordinal regression models to fit the ordinal survey outcomes of risk perceptions to the continuous HOMA-IR and weight outcome variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRA+genetic test | Active Comparator | patients 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 Intervention | Patients randomized to not get genetic testing will be followed and surveyed and will be counseled based on SRA only | |
| no testing control | No Intervention | Patients not interested in genetic testing will be followed and surveyed. Counseling will be based on SRA only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Risk Assessment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of weight loss | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in perceptions of personal risk for Type 2 diabetes | 12 months | |
| Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Family Medicine at Pickens | Durham | North Carolina | 27705 | United States | ||
| Duke Health Center at Pickett Rd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22302620 | Derived | 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. | |
| 22257365 | Derived | Cho 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Durham |
| North Carolina |
| 27705 |
| United States |
| D004700 | Endocrine System Diseases |