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NCT01386801Active, not recruiting

Multicenter Research Study to Build a Repository to Study Chronic Diseases in Indiana

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

Source: ClinicalTrials.gov · Last updated 6 Sept 2013

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
30 Jun 2011
Start date
Dec 2009
Primary completion date
Dec 2049
Lead sponsor
Fairbanks Institute
NCT number
NCT01386801

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From Dec 2009 to the primary completion date, Dec 2049
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Non-autologous bone marrow transplant

Other illness

  • Hepatitis B
  • Hepatitis C
  • AIDS (HIV positive)
  • Tuberculosis
  • Cancer (including melanoma, but excluding low-malignancy skin cancer)

Other

  • Blood transfusion within 120 days

Who the study is looking for

  • 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.
    • \-

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
American Health Network
Coordinator of this site? Confirm its status
AvonUnited StatesUnknown status
Investigator's Research Group
Coordinator of this site? Confirm its status
BrownsburgUnited StatesUnknown status
American Health Network
Coordinator of this site? Confirm its status
FranklinUnited StatesUnknown status
American Health Network
Coordinator of this site? Confirm its status
GreenfieldUnited StatesUnknown status
American Health Network
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Krannert Cardiology
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Oral Health Research Institute
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
IU School of Medicine/CTSI
Coordinator of this site? Confirm its status
Indianapolis (Downtown)United StatesUnknown status
IU Medical Group
Coordinator of this site? Confirm its status
Indianapolis (Spanish/English Speaking)United StatesUnknown status
Alivio Medical Center
Coordinator of this site? Confirm its status
Indianapolis (Spanish Speaking)United StatesUnknown status
American Health Network
Coordinator of this site? Confirm its status
MuncieUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.