NCT00330954

Brief Summary

One of the goals of the Kansas City Diabetes Consortium is to identify and characterize genes and their products that are associated with T1DM. Characterization of such genes and their products can aid in developing new tools for risk assessment, development of new prevention strategies and monitoring progression of disease. Study design: Descriptive, basic science pilot study. The results of this pilot study will be used to help design a much larger study to address the importance of viral response and autoimmune diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 5, 2010

Status Verified

March 1, 2010

First QC Date

May 26, 2006

Last Update Submit

March 3, 2010

Conditions

Keywords

viral response genes

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Male and female subjects 7-14 years of age * New onset T1DM * Five years post onset of T1DM

You may qualify if:

  • Male and female subjects 7-14 years of age
  • New onset T1DM
  • Five years post onset of T1DM
  • Participant in the TrialNet initiative and either antibody positive or antibody negative sibling control
  • Body weight sufficient to tolerate an additional 15ml (1 tbsp) blood loss

You may not qualify if:

  • Subjects who do not meet the criteria above
  • Subjects who have received steroids or other immunosuppressive therapy within the 6 months prior to enrollment into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood saved frozen for 1 year

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Karen Kover, PhD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 29, 2006

Study Start

June 1, 2006

Study Completion

April 1, 2008

Last Updated

March 5, 2010

Record last verified: 2010-03

Locations