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TODAY Genetics Study

2021年7月28日更新者：National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Genetics Study

The TODAY study group has prepared a protocol with the primary objective of collecting blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Participation in the genetics study includes a blood draw for analysis of diabetes type and DNA extraction, as well as collection of basic family and medical history. Appropriate informed consent and assent are obtained from all participants to extract DNA and send blood, genetic material, and medical history to the Central Repository of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The data are kept indefinitely by the Central Repository. The NIDDK will issue requests for proposals (RFP) throughout the scientific community for research that may help in the development of new diagnostic tests, new treatments, and new ways to prevent diabetes and other related comorbidities.

研究概览

地位

完全的

条件

2型糖尿病

研究类型

观察性的

注册 (实际的)

2654

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Arkansas
  - Little Rock、Arkansas、美国、72202
    - UAMS Arkansas Children's Hospital
- California
  - Los Angeles、California、美国、90027
    - Childrens Hospital Los Angeles
  - San Diego、California、美国、92123
    - UCSD Rady Children's Hospital
- Colorado
  - Aurora、Colorado、美国、80045
    - University of Colorado Denver
- Connecticut
  - Hartford、Connecticut、美国、06106
    - Connecticut Children's Medical Center
  - New Haven、Connecticut、美国、06519
    - Yale University
- Florida
  - Gainesville、Florida、美国、32611
    - University of Florida
- Georgia
  - Atlanta、Georgia、美国、30322
    - Emory University
- Indiana
  - Indianapolis、Indiana、美国、46202
    - Indiana University School of Medicine
- Maryland
  - Rockville、Maryland、美国、20852
    - George Washington University Biostatistics Center
- Massachusetts
  - Boston、Massachusetts、美国、02114
    - Massachusetts General Hospital
  - Boston、Massachusetts、美国、02215
    - Joslin Diabetes Center
- Missouri
  - Kansas City、Missouri、美国、64108
    - Kansas City Children's Mercy Hospital
  - Saint Louis、Missouri、美国、63110
    - Washington University
  - Saint Louis、Missouri、美国、63104
    - St Louis University
- New York
  - New York、New York、美国、10032
    - Columbia University
  - Syracuse、New York、美国、13214
    - State University of New York Upstate Medical University
- Ohio
  - Cleveland、Ohio、美国、44106
    - Case Western Reserve University
- Oklahoma
  - Oklahoma City、Oklahoma、美国、73117
    - University of Oklahoma
- Pennsylvania
  - Philadelphia、Pennsylvania、美国、19104
    - Children's Hospital of Philadelphia
  - Pittsburgh、Pennsylvania、美国、15213
    - Children's Hospital of Pittsburgh
- Tennessee
  - Nashville、Tennessee、美国、37232
    - Vanderbilt University Medical Center
- Texas
  - Houston、Texas、美国、77030
    - Baylor College of Medicine
  - Lubbock、Texas、美国、79430
    - Texas Tech University Health Science Center
  - San Antonio、Texas、美国、78207
    - University of Texas Health Science Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Recruitment is conducted within a 'catchment' area that includes (a) the patient pools of the 15 TODAY clinical centers and (b) collaborating clinics and physicians who either refer subjects to a TODAY site or obtain IRB approval to conduct the protocol at their own locale.

描述

Inclusion Criteria:

Diabetes by ADA criteria (laboratory determinations of fasting glucose ≥ 126 mg/dL, random glucose ≥ 200 mg/dL, or two-hour oral glucose tolerance test (OGTT) glucose ≥ 200 mg/dL) documented and confirmed in medical record or a laboratory determination of HbA1c ≥ 7%. For asymptomatic patients diagnosed with diabetes with a normal fasting glucose but an elevated two-hour glucose during an OGTT, the HbA1c must be ≥ 6%.
BMI ≥ 85th percentile documented at time of diagnosis or at screening.
Age < 18 at time of diagnosis.
Signed informed consent and assent forms as appropriate.

Exclusion Criteria:

Genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
Patient on medication known to affect glucose tolerance, insulin sensitivity or secretion within 60 days of the time of diagnosis. If diagnosis is confirmed after the patient has been off the medication for 60 days, the patient may be included. Exclusionary medications include but are not limited to
1. inhaled steroids at dose above 1000 mcg daily fluticasone equivalent,
2. oral glucocorticoids,
3. antirejection or chemotherapy agents (e.g., tacrolimus, L-asparaginase),
4. atypical antipsychotics.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Blood draw to be processed and analyzed to yield genetic data. 大体时间：Blood is drawn at the single study visit.	Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository.	Blood is drawn at the single study visit.

次要结果测量

结果测量	措施说明	大体时间
Phenotype data. 大体时间：Collected at single study visit.	Demographic, medical history, and other data about participant and family, by self-report.	Collected at single study visit.
Laboratory values. 大体时间：Single study visit.	Serum glucose, C-peptide, and pancreatic autoimmunity antibodies determined by study central laboratory.	Single study visit.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

调查人员

首席研究员：Kathryn Hirst, PhD、George Washington University
首席研究员：Phil Zeitler, MD PhD、University of Colorado, Denver

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Srinivasan S, Chen L, Todd J, Divers J, Gidding S, Chernausek S, Gubitosi-Klug RA, Kelsey MM, Shah R, Black MH, Wagenknecht LE, Manning A, Flannick J, Imperatore G, Mercader JM, Dabelea D, Florez JC; ProDiGY Consortium. The First Genome-Wide Association Study for Type 2 Diabetes in Youth: The Progress in Diabetes Genetics in Youth (ProDiGY) Consortium. Diabetes. 2021 Apr;70(4):996-1005. doi: 10.2337/db20-0443. Epub 2021 Jan 21. Erratum In: Diabetes. 2021 Oct 29;:

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年8月1日

初级完成 (实际的)

2015年2月1日

研究完成 (实际的)

2015年2月1日

研究注册日期

首次提交

2008年7月23日

首先提交符合 QC 标准的