Multicenter Research Study to Build a Repository to Study Chronic Diseases in Indiana (IHS)
Multicenter Research Study to Build a Repository That Will Allow Researchers to Study Chronic Diseases in the Population of Central Indiana
調査の概要
状態
条件
詳細な説明
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include two follow up visit and continue indefinitely, unless, of course, at any time, consent for further follow-up is withdrawn by the subject.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
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Indiana
-
Avon、Indiana、アメリカ
- American Health Network
-
Brownsburg、Indiana、アメリカ
- Investigator's Research Group
-
Franklin、Indiana、アメリカ
- American Health Network
-
Greenfield、Indiana、アメリカ
- American Health Network
-
Indianapolis、Indiana、アメリカ
- American Health Network
-
Indianapolis、Indiana、アメリカ
- Krannert Cardiology
-
Indianapolis、Indiana、アメリカ
- Oral Health Research Institute
-
Indianapolis (Downtown)、Indiana、アメリカ
- IU School of Medicine/CTSI
-
Indianapolis (Spanish speaking)、Indiana、アメリカ
- Alivio Medical Center
-
Indianapolis (Spanish/English speaking)、Indiana、アメリカ
- IU Medical Group
-
Muncie、Indiana、アメリカ
- American Health Network
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
People with Diabetes Mellitus Type II
500 subjects will have T2D
|
|
Healthy
500 persons who do not have T2D, hypertension or hypercholesterol
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Anantha Shekhar, MD、Indiana University School of Medine/CTSI
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。