An interventional study of Standardized Risk Assessment in Diabetes Mellitus, Type 2, sponsored by Duke University. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-10.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 450 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Duke University is the lead sponsor of 2,025 studies on the registry; 277 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 158 (81%) have results posted.
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Exclusion Criteria:
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
Other: Standardized Risk Assessment
Patients randomized to not get genetic testing will be followed and surveyed and will be counseled based on SRA only
Patients not interested in genetic testing will be followed and surveyed. Counseling will be based on SRA only
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.
Percentage of weight loss
Time frame: 12 months
Change in perceptions of personal risk for Type 2 diabetes
Time frame: 12 months
Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 12 months
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Duke University