Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes (TDE)
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27705
- Duke Family Medicine at Pickens
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Durham, North Carolina, 미국, 27705
- Duke Health Center at Pickett Rd
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: SRA+genetic test
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
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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.
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간섭 없음: SRA only
Patients randomized to not get genetic testing will be followed and surveyed and will be counseled based on SRA only
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간섭 없음: no testing control
Patients not interested in genetic testing will be followed and surveyed.
Counseling will be based on SRA only
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Percentage of weight loss
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in perceptions of personal risk for Type 2 diabetes
기간: 12 months
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12 months
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Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR)
기간: 12 months
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12 months
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Geoffrey Ginsburg, Md, PhD, Institute for Genome Sciences and Policy, Duke University
- 수석 연구원: Alex Cho, MD, Institute for Genome Sciences and Policy, Duke University
- 수석 연구원: Scott Joy, MD, Duke University
- 수석 연구원: Susanne Haga, PhD, Institute for Genome Sciences and Policy, Duke University
- 수석 연구원: Isaac Lipkus, PhD, Institute for Genome Sciences and Policy, Duke University
- 수석 연구원: Gloria Trujillo, MD, Duke University
- 수석 연구원: Julianne O'Daniel, PhD, Institute for Genome Sciences and Policy, Duke University
간행물 및 유용한 링크
일반 간행물
- Waxler JL, O'Brien KE, Delahanty LM, Meigs JB, Florez JC, Park ER, Pober BR, Grant RW. Genetic counseling as a tool for type 2 diabetes prevention: a genetic counseling framework for common polygenetic disorders. J Genet Couns. 2012 Oct;21(5):684-91. doi: 10.1007/s10897-012-9486-x.
- Cho AH, Killeya-Jones LA, O'Daniel JM, Kawamoto K, Gallagher P, Haga S, Lucas JE, Trujillo GM, Joy SV, Ginsburg GS. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design. BMC Health Serv Res. 2012 Jan 18;12:16. doi: 10.1186/1472-6963-12-16.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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