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临床试验/NCT01060540
NCT01060540已完成不适用

The Impact of Genetic Testing for Type 2 Diabetes on Health Behaviors

US Department of Veterans Affairs2 个研究点 分布在 1 个国家目标入组 601 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
601
试验地点
2
主要终点
Weight

研究概览

简要总结

In this 6-month randomized, controlled trial, we examined whether providing participants with genetic test results and counseling regarding their risk for type 2 diabetes would motivate them to improve their health behaviors and lose weight to reduce their diabetes risk. We hypothesized that participants who received conventional diabetes counseling plus genetic test results and counseling would have at least 6 lb greater weight loss at 3 months than participants who received conventional diabetes counseling without genetic test results.

详细描述

In this 6-month randomized, controlled trial, we evaluated the impact of genetic testing for type 2 diabetes on psychological, health behavior, and clinical outcomes. Eligibility criteria included age 21 to 65 years, overweight or obese (body mass index [BMI] >27 kg/m2), and no prior diagnosis of type 2 diabetes. At baseline, participants (N=601) had conventional risk factors assessed, including demographics, fasting plasma glucose (FPG), and family history. They also provided blood samples for genetic testing of TCF7L2, PPARG, and KCNJ11, three genes that confer elevated risk for development of type 2 diabetes. Participants were then randomized to receive conventional counseling plus control eye disease counseling (CR+EYE) or conventional counseling plus genetic test results (CR+G). Two to four weeks following the baseline visit, when the genetic test results were available, participants returned for a visit with a genetic counselor. All participants received conventional risk counseling based on their lifetime population risk, FPG results, and family history. Next, participants were informed of their randomization assignments; CR+EYE participants received counseling on eye diseases, whereas CR+G participants received genetic counseling. Then perceived risk, affect, self-efficacy, and readiness to change were assessed. All other outcomes were also assessed at 3 and 6 months.

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 (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • body mass index >27 kg/m2
  • baseline fasting plasma glucose <=125 mg/dL

排除标准

  • prior diagnosis of type 2 diabetes
  • fasting plasma glucose >125 mg/dL on more than one occasion
  • HbA1c > 7%
  • taking diabetes medication
  • actively losing weight
  • enrolled in research study focusing on lifestyle changes
  • unable to provide informed consent or answer survey questions unassisted
  • residing in nursing home or receiving home health care
  • active diagnosis of psychosis or dementia
  • at least one error on 6-item cognitive screener

结局指标

主要结局

Weight

时间窗: 3 months

weight 3 months post-enrollment

次要结局

  • Daily Caloric Intake(3 months)
  • Insulin Resistance (HOMA2-IR)(3 months)
  • Moderate Intensity Physical Activity(3 months)
  • Perceived Lifetime Risk of Type 2 Diabetes(3 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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