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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Indiana University School of Medicine
Richard M. Fairbanks Foundation
BioCrossroads
Regenstrief Institute, IU Center for Aging Research
Information provided by:
Fairbanks Institute
ClinicalTrials.gov Identifier:
NCT01386801
First received: June 30, 2011
Last updated: September 5, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by Fairbanks Institute:

Biospecimen Retention:   Samples With DNA

DNA = 1 Serum = 2 Plasma = 2 RNA = 2


Estimated Enrollment: 1000
Study Start Date: December 2009
Estimated Study Completion Date: June 2050
Estimated Primary Completion Date: December 2049 (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
Study Population

People living in the state of Indiana

Criteria

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.

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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386801

Locations
United States, Indiana
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
Oral Health Research Institute
Indianapolis, Indiana, United States
Krannert Cardiology
Indianapolis, Indiana, United States
American Health Network
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, United States
Sponsors and Collaborators
Fairbanks Institute
Indiana University School of Medicine
Richard M. Fairbanks Foundation
BioCrossroads
Regenstrief Institute, IU Center for Aging Research
Investigators
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 5, 2013
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 July 26, 2014