Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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