NCT00918801

Brief Summary

This study is an expansion of a previous study done to determine how thinking skills relate to hypoglycemia (low blood sugar) and certain regions of the brain in children and adolescents. In this study, the investigators are testing thinking skills and measuring brain activity in adolescents with and without type 1 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

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

Study Start

First participant enrolled

April 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

6.7 years

First QC Date

June 8, 2009

Last Update Submit

November 9, 2016

Conditions

Type 1 Diabetes Mellitus

Keywords

T1DMMRI

Study Arms (2)

Type 1 Diabetes Mellitus

Adolescents ages 13-18 with T1DM

Non Controls

Healthy adolescents ages 13-18 without T1DM

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young adults will be piloted in a sample of diabetic and non-diabetic adolescents ages 13-18.

You may qualify if:

  • Age 13 - 18
  • Right handed
  • Diagnosis of Type 1 Diabetes OR normal sibling control
  • If diabetic, then diagnosis for at least 2 years

You may not qualify if:

  • Pregnant or lactating
  • Chronic disease other than well-controlled asthma, or Hashimoto's thyroiditis.
  • Other current serious medical illness
  • Co-morbid psychiatric illness
  • Co-morbid neurological illness
  • Pre-maturity at birth
  • Contraindication to MRI scan
  • orthodontic braces.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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

  • Tamara G Hershey, PhD.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 11, 2009

Study Start

April 1, 2007

Primary Completion

December 1, 2013

Study Completion

October 1, 2016

Last Updated

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

This was a small pilot study and consent was not obtained to share data.

Locations

US(1)