Diabetes Mellitus Type IIIHSNCT01386801
Multicenter Research Study to Build a Repository to Study Chronic Diseases in Indiana
An observational study of Diabetes Mellitus Type II, run by Fairbanks Institute at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type II
- How many people
- 1,000 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2009to Jun 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People living in the state of Indiana
Who may be able to join
- 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.
Show all 20Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
American Health Network
Avon, Indiana
Investigator's Research Group
Brownsburg, Indiana
American Health Network
Franklin, Indiana
American Health Network
Greenfield, Indiana
American Health Network
Indianapolis, Indiana
Krannert Cardiology
Indianapolis, Indiana
Oral Health Research Institute
Indianapolis, Indiana
IU School of Medicine/CTSI
Indianapolis (Downtown), Indiana
Alivio Medical Center
Indianapolis (Spanish Speaking), Indiana
IU Medical Group
Indianapolis (Spanish/English Speaking), Indiana
American Health Network
Muncie, Indiana
About this study
Official title: Multicenter Research Study to Build a Repository That Will Allow Researchers to Study Chronic Diseases in the Population of Central Indiana
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.
Read the 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
- Conditions
- Diabetes Mellitus Type II
- Keywords
- Diabetes, Controls, Biospecimen
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with Diabetes Mellitus Type II | 500 subjects will have T2D | |
| Healthy | 500 persons who do not have T2D, hypertension or hypercholesterol |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startDec 2009
- Primary completionDec 2049 (estimated)
- Study completionJun 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fairbanks Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Richard M. Fairbanks Foundation, BioCrossroads, Regenstrief Institute, Inc.
- Investigators
- Anantha Shekhar, MD, Principal investigator, Indiana University School of Medine/CTSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386801
- Sponsor's protocol ID
- FIHC-2009-01
- Acronym
- IHS
- Status last verified
- Aug 2013
- First submitted
- 30 Jun 2011
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Research Study to Build a Repository That Will Allow Researchers to Study Chronic Diseases in the Population of Central Indiana
- ClinicalTrials.gov ID
- NCT01386801
- Acronym / sponsor ID
- IHS / FIHC-2009-01
- Conditions
- Diabetes Mellitus Type II
- Keywords
- Diabetes, Controls, Biospecimen
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fairbanks InstituteUniversity, hospital or other
- Collaborators
- Indiana University, Richard M. Fairbanks Foundation, BioCrossroads, Regenstrief Institute, Inc.
- Study start
- Dec 2009
- Primary completion
- Dec 2049 (estimated)
- Study completion
- Jun 2050 (estimated)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with Diabetes Mellitus Type II | – | –500 subjects will have T2D |
| Healthy | – | –500 persons who do not have T2D, hypertension or hypercholesterol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People living in the state of Indiana
Key inclusion criteria (20 listed)
- 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%
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
- Accelerated Clinical and Translational ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anantha Shekhar, MD principal investigator
Indiana University School of Medine/CTSI
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type II, run by Fairbanks Institute at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013.