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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
SRA+genetic test	Standardized Risk Assessment	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

Primary Outcome Measures

Name	Time	Method
Percentage of weight loss	12 months

Secondary Outcome Measures

Name	Time	Method
Change in perceptions of personal risk for Type 2 diabetes	12 months
Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR)	12 months

Locations (2): Duke Family Medicine at Pickens
🇺🇸
Durham, North Carolina, United States
Duke Health Center at Pickett Rd
🇺🇸
Durham, North Carolina, United States

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