Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM) (LO5/HY5)

October 31, 2016 updated by: Washington University School of Medicine

Glycemic Control, Brain Structure and Cognition in Youth With T1DM

LO5 study: The investigators are inviting a new group of youth (ages 7-16) who have been recently diagnosed with type 1 diabetes and their non-diabetic siblings. These youth will complete cognitive tests and a MRI scan of the brain. This scan uses strong magnets to obtain pictures and does not involve any radiation or injections. The investigators will recruit patients within three months of their diagnosis date. The study entails 1 study visit that lasts 3.5 hours. Evening and weekend times are available. The investigators plan to enroll 135 participants.

HY5 study: The investigators are inviting a cohort of youth and young adults (ages 9-21) with type 1 diabetes and their non-diabetic siblings for a follow-up to a study they have already completed. This group of people will complete several memory and thinking tests along with several MRI scans of their brain, just as they did at their previous visits. The investigators plan to enroll 150 participants.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

LO5: Youth with type 1 diabetes (T1DM) between the ages of 7-16 who have been diagnosed within the previous 3 months. Non-diabetic siblings of the participants with T1DM aged 7-16 years old.

HY5: Youth and young adults (ages 9-21) who have already completed an earlier study with the lab.

Description

LO5:

Inclusion Criteria for Participants with Type 1 Diabetes:

  • Between the ages of 7 and 16
  • Diagnosed with type 1 diabetes within 3 months

Inclusion Criteria for Participants without Type 1 Diabetes:

  • Between the ages of 7 and 16

Exclusion Criteria for Participants with Type 1 Diabetes:

  • Pregnant or lactating
  • Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis
  • Other current serious medical illness
  • Psychiatric illness
  • Psychoactive drug dependence
  • Neurological illness (except T1DM-related): stroke, seizure, major loss of consciousness, head injuries, encephalitis, or hydrocephalus, blindness, deafness
  • Use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed)
  • Use of dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall
  • Pre-maturity at birth of more than 4 wks early with complications (e.g. on respirator at NICU)
  • Inability to complete MRI scan (e.g. claustrophobia, metal implants)
  • Full set (top and bottom) of orthodontic braces (Half set braces, fillings, and retainers are OK)

Exclusion Criteria for Participants without Type 1 Diabetes:

  • Same as above (except cannot have type 1 diabetes)

HY5: Must have been a participant in our earlier study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Type 1 Diabetes (T1DM)
Youth and young adults with T1DM
Non diabetic siblings
Non diabetic, young siblings of T1DM participants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Tamara G. Hershey, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria

April 8, 2009

First Posted (Estimate)

April 9, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-1258
  • R01DK064832-06 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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