Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Standardized Risk Assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SRA+genetic test<br>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<br>* 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.<br>|
| No Intervention: SRA only<br>Patients randomized to not get genetic testing will be followed and surveyed and will be counseled based on SRA only | |
| No Intervention: no testing control<br>Patients not interested in genetic testing will be followed and surveyed. Counseling will be based on SRA only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of weight loss |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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predictive genomics, personalized medicine, personal genomics, genetic knowledge, genetic attitudes, prevention, health outcomes, behavioral