NCT01386801

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
290mo left

Started Dec 2009

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Dec 2009Jun 2050

Study Start

First participant enrolled

December 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed
38.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2049

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2050

Last Updated

September 6, 2013

Status Verified

August 1, 2013

Enrollment Period

40 years

First QC Date

June 30, 2011

Last Update Submit

September 5, 2013

Conditions

Diabetes Mellitus Type II

Keywords

DiabetesControlsBiospecimen

Study Arms (2)

People with Diabetes Mellitus Type II

500 subjects will have T2D

Healthy

500 persons who do not have T2D, hypertension or hypercholesterol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People living in the state of Indiana

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

American Health Network

Avon, Indiana, United States

Location

Investigator's Research Group

Brownsburg, Indiana, United States

Location

American Health Network

Franklin, Indiana, United States

Location

American Health Network

Greenfield, Indiana, United States

Location

American Health Network

Indianapolis, Indiana, United States

Location

Krannert Cardiology

Indianapolis, Indiana, United States

Location

Oral Health Research Institute

Indianapolis, Indiana, United States

Location

IU School of Medicine/CTSI

Indianapolis (Downtown), Indiana, United States

Location

Alivio Medical Center

Indianapolis (Spanish Speaking), Indiana, United States

Location

IU Medical Group

Indianapolis (Spanish/English Speaking), Indiana, United States

Location

American Health Network

Muncie, Indiana, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Anantha Shekhar, MD

    Indiana University School of Medine/CTSI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 1, 2011

Study Start

December 1, 2009

Primary Completion (Estimated)

December 1, 2049

Study Completion (Estimated)

June 1, 2050

Last Updated

September 6, 2013

Record last verified: 2013-08

Locations

US(11)