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| ID | Type | Description | Link |
|---|---|---|---|
| R21DK084527 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. Intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. Controls will not be tested. All subjects will be enrolled in a 12-week diabetes prevention program.
This study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. We will randomize subjects with pre-diabetes to genetic testing vs. no genetic testing in order to obtain an unconfounded test of the hypothesis that genetic testing will change patient behavior. Intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. Because patients can receive either "Higher risk" or "Lower risk" genetic test results, we will separately examine the impact of "Higher risk" and "Lower risk" test results compared to untested controls. All subjects will be enrolled in a 12-week diabetes prevention program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Genetic Counseling | Experimental | Subjects will have been genotyped and will received genetic counseling based on their results |
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| No Genotyping or Counseling | Placebo Comparator | Patients will not be genotyped and will therefore not receive genetic counseling |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Genetic Counseling | Behavioral | Subjects will be genotyped based on a 37-allele aggregate score and counseled regarding the implications of the results prior to enrollment in a 12-week diabetes prevention program |
| Measure | Description | Time Frame |
|---|---|---|
| stage of change | baseline, after counseling, after completing program (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| program attendance | 3 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard W Grant, MD MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Practice Based Research Network | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22933432 | Derived | Grant RW, O'Brien KE, Waxler JL, Vassy JL, Delahanty LM, Bissett LG, Green RC, Stember KG, Guiducci C, Park ER, Florez JC, Meigs JB. Personalized genetic risk counseling to motivate diabetes prevention: a randomized trial. Diabetes Care. 2013 Jan;36(1):13-9. doi: 10.2337/dc12-0884. Epub 2012 Aug 28. | |
| 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. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D050177 | Overweight |
| D024821 | Metabolic Syndrome |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| No genetic counseling | Behavioral | These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program |
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| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |