Diabetes Mellitus Type II Clinical Trial
— IHSOfficial title:
Multicenter Research Study to Build a Repository That Will Allow Researchers to Study Chronic Diseases in the Population of Central Indiana
Verified date | August 2013 |
Source | Fairbanks Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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 | Active, not recruiting |
Enrollment | 1000 |
Est. completion date | June 2050 |
Est. primary completion date | December 2049 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | American Health Network | Avon | Indiana |
United States | Investigator's Research Group | Brownsburg | Indiana |
United States | American Health Network | Franklin | Indiana |
United States | American Health Network | Greenfield | Indiana |
United States | American Health Network | Indianapolis | Indiana |
United States | Krannert Cardiology | Indianapolis | Indiana |
United States | Oral Health Research Institute | Indianapolis | Indiana |
United States | IU School of Medicine/CTSI | Indianapolis (Downtown) | Indiana |
United States | Alivio Medical Center | Indianapolis (Spanish speaking) | Indiana |
United States | IU Medical Group | Indianapolis (Spanish/English speaking) | Indiana |
United States | American Health Network | Muncie | Indiana |
Lead Sponsor | Collaborator |
---|---|
Fairbanks Institute | BioCrossroads, Indiana University School of Medicine, Regenstrief Institute, Inc., Richard M. Fairbanks Foundation |
United States,
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