Diabetes Mellitus, Type 2
Conditions
Keywords
predictive genomics, personalized medicine, personal genomics, genetic knowledge, genetic attitudes, prevention, health outcomes, behavioral
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 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.
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 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.
Interventions
OTHERStandardized Risk Assessment
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.
Sponsors
deCODE genetics
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of weight loss | 12 months |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed