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Multicenter Research Study to Build a Repository to Study Chronic Diseases in Indiana (IHS)

2013年9月5日 更新者：Fairbanks Institute

Multicenter Research Study to Build a Repository That Will Allow Researchers to Study Chronic Diseases in the Population of Central Indiana

Blood samples and health information (e.g., age at diagnosis, test results) are collected for the purposes of genetic research. The blood samples are assigned a number and stored in a repository for safe keeping until they are needed for a research project. Participants are persons who are healthy (not having high blood pressure, diabetes, or high cholesterol levels) or persons who have Diabetes Mellitus Type II(T2D) and live in Indiana. Participants complete a questionnaire at the time the blood sample is drawn. Visits are repeated at 2 and 5 years after initial contact. Researchers apply to the Fairbanks Institute for use of the blood samples and health information minus participant names and contact information. Their research is required to be related to find genes or substances made by genes that may be involved in Diabetes Mellitus Type II with the purpose of improving the investigators understanding of the illness potentially leading to the development of new diagnostic tools for identifying the illness, new treatments,or preventative measures.

研究概览

地位

主动，不招人

条件

详细说明

Study Aim:

The purpose of this study is to create an extensively annotated bio-repository platform for hypothesis-driven research that will lead to advancements in the diagnosis, treatment and prevention of diseases common to the population of Indiana. The second phase of this research platform will be created by collecting blood samples from two groups of individuals in the Central Indiana community, one with documented evidence of Diabetes Mellitus Type II(T2D), and a second group of age, gender and ethnicity matched individuals without clinical evidence of Diabetes. Each individual's blood sample will be linked to their clinical, demographic and epidemiological information, gathered both retrospectively and prospectively.

Recruitment:

This study will include 500 individuals with T2D (the T2D Group) and 500 individuals who are age, gender, and ethnicity matched to the T2D Group, but without presentation of clinical evidence of T2D (the Control Group). To reflect the growing representation of Hispanics in Central Indiana, Hispanics will be overly recruited in both groups so that the study population accurately reflects the general population of Central Indiana.

Follow-up:

As this is a prospective, longitudinal study, follow-up of study subjects is intended to include two follow up visit and continue indefinitely, unless, of course, at any time, consent for further follow-up is withdrawn by the subject. Follow-up will include visits at 2 and 5 years post initial contact and continuing access to the subject's medical record to pursue data concerning changes in the subject's health. Subjects may be contacted by telephone, mail or email every twelve months to ask if they wish to continue participation in the study. The 2 and 5 year follow up visits mirror the initial visit.

The collected dataset (made up of the collected blood samples linked to clinical and epidemiological information collected retrospectively and prospectively), will be used in medical research to find genes, or gene products such as RNA or proteins that will help in understanding the causes of disease and will guide the development of new treatments

研究类型

观察性的

注册 (预期的)

1000

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
    • Indiana
      • Avon、Indiana、美国
        • American Health Network
      • Brownsburg、Indiana、美国
        • Investigator's Research Group
      • Franklin、Indiana、美国
        • American Health Network
      • Greenfield、Indiana、美国
        • American Health Network
      • Indianapolis、Indiana、美国
        • American Health Network
      • Indianapolis、Indiana、美国
        • Krannert Cardiology
      • Indianapolis、Indiana、美国
        • Oral Health Research Institute
      • Indianapolis (Downtown)、Indiana、美国
        • IU School of Medicine/CTSI
      • Indianapolis (Spanish speaking)、Indiana、美国
        • Alivio Medical Center
      • Indianapolis (Spanish/English speaking)、Indiana、美国
        • IU Medical Group
      • Muncie、Indiana、美国
        • American Health Network

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

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

People living in the state of Indiana

描述

Inclusion Criteria:T2D Group

Study subjects will be recruited for the T2D group based on a history confirmed by the medical record of at least one of the following:

  • A fasting blood glucose of greater than or equal to 126 mg/dL on two separate occasions
  • A random (non-fasting) blood glucose of greater than or equal to 200 mg/dL on two separate occasions
  • A blood glucose of greater than 200 mg/dL at 2 hours during a standard oral glucose tolerance test
  • A HgbA1c of greater than or equal to 6.5%

Females who are pregnant will be excluded.

Control Group

Study subjects for the Control Group will have:

  • no confirmed history of T2D as defined above
  • A fasting blood glucose of 100 mg/dL or less

Medical records will be obtained to ensure subjects meet study inclusion criteria.

-

Exclusion Criteria:Exclusion criteria for both the T2D Group and the Control Group are a known or reported history of:

  • Hepatitis B
  • Hepatitis C
  • AIDS (HIV positive)
  • Tuberculosis
  • Cancer (including melanoma, but excluding low-malignancy skin cancer)
  • Non-autologous bone marrow transplant
  • Blood transfusion within 120 days

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

队列和干预

团体/队列
People with Diabetes Mellitus Type II
500 subjects will have T2D
Healthy
500 persons who do not have T2D, hypertension or hypercholesterol

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

Fairbanks Institute

合作者

Regenstrief Institute, Inc.
Indiana University School of Medicine
Richard M. Fairbanks Foundation
BioCrossroads

调查人员

  • 首席研究员：Anantha Shekhar, MD、Indiana University School of Medine/CTSI

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。

有用的网址

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

2009年12月1日

初级完成 (预期的)

2049年12月1日

研究完成 (预期的)

2050年6月1日

研究注册日期

首次提交

2011年6月30日

首先提交符合 QC 标准的

2011年6月30日

首次发布 (估计)

2011年7月1日

研究记录更新

最后更新发布 (估计)

2013年9月6日

上次提交的符合 QC 标准的更新

2013年9月5日

最后验证

2013年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • FIHC-2009-01

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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