Multicenter Research Study to Build a Repository to Study Chronic Diseases in Indiana (IHS)
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Purpose
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.
| Condition |
|---|
|
Diabetes Mellitus Type II |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Multicenter Research Study to Build a Repository That Will Allow Researchers to Study Chronic Diseases in the Population of Central Indiana |
DNA = 1 Serum = 2 Plasma = 2 RNA = 2
| Estimated Enrollment: | 1000 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
People with Diabetes Mellitus Type II
500 subjects will have T2D
|
|
Healthy
500 persons who do not have T2D, hypertension or hypercholesterol
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
People living in the state of Indiana
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
Contacts and Locations| Contact: Brooke Patz | 317-238-2483 | bpatz@fairbanksinstitute.org |
| Contact: Mary Ann Caldwell, RN | 317-274-8915 | macaldwe@iupui.edu |
| United States, Indiana | |
| American Health Network | Recruiting |
| Avon, Indiana, United States | |
| Contact: Carla Cravens 317-745-8000 ext 453 carla_cravens@ahni.com | |
| Principal Investigator: Mary Schmoll, NP | |
| Investigator's Research Group | Recruiting |
| Brownsburg, Indiana, United States | |
| Contact: Rod Rapheal 317-297-7999 investigatorsresearch@yahoo.com | |
| Principal Investigator: Kenneth Maynard, DO | |
| American Health Network | Recruiting |
| Franklin, Indiana, United States | |
| Contact: Michelle Meier 317-738-7448 michelle_meier@ahni.com | |
| Contact: Christine Wathen 317-738-7448 christine_wathen@ahni.com | |
| Principal Investigator: Jill Beavins, MD | |
| American Health Network | Recruiting |
| Greenfield, Indiana, United States | |
| Contact: Vickie McDaniel 317-462-5252 ext 248 vickie_Mcdaniel@ahni.com | |
| Principal Investigator: Stephanie Kinnaman, MD | |
| Oral Health Research Institute | Recruiting |
| Indianapolis, Indiana, United States | |
| Contact: Melissa Mau 317-274-5439 mmau@iupui.edu | |
| Principal Investigator: Ana Gossweiler, DDS | |
| Krannert Cardiology | Recruiting |
| Indianapolis, Indiana, United States | |
| Contact: Jeri Steward 317-962-0080 Steward3@iupui.edu | |
| Principal Investigator: Jacqueline O'Donnell, MD | |
| American Health Network | Active, not recruiting |
| Indianapolis, Indiana, United States | |
| IU School of Medicine/CTSI | Recruiting |
| Indianapolis (Downtown), Indiana, United States | |
| Contact: Mary Ann Caldwell, RNC CCRC 317-274-8915 macaldwe@iupui.edu | |
| Principal Investigator: Anantha Shekhar, MD PhD | |
| Alivio Medical Center | Recruiting |
| Indianapolis (Spanish speaking), Indiana, United States | |
| Contact: Jorge Ayala 317-501-4189 jorfa@comcast.net | |
| Principal Investigator: Alfredo Lopez, MD | |
| IU Medical Group | Recruiting |
| Indianapolis (Spanish/English speaking), Indiana, United States | |
| Contact: Elaine Rivera 317-278-6163 erivera2@IUhealth.org | |
| Principal Investigator: Javier Sevilla, MD | |
| American Health Network | Recruiting |
| Muncie, Indiana, United States | |
| Contact: Adrian White adrain_white@ahni.com | |
| Principal Investigator: Jonathan Condit, DO | |
| Principal Investigator: | Anantha Shekhar, MD | Indiana University School of Medine/CTSI |
More Information
Additional Information:
No publications provided
| Responsible Party: | Cynthia Helphingstine, Fairbanks Institute for Healthy Communities |
| ClinicalTrials.gov Identifier: | NCT01386801 History of Changes |
| Other Study ID Numbers: | FIHC-2009-01 |
| Study First Received: | June 30, 2011 |
| Last Updated: | September 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fairbanks Institute:
|
Diabetes Controls Biospecimen |
Additional relevant MeSH terms:
|
Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes |
Pathologic Processes Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013