Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- Percentage of weight loss
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of weight loss
时间窗: 12 months
次要结局
- Change in perceptions of personal risk for Type 2 diabetes(12 months)
- Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR)(12 months)
