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Pilot Study of Hippocampal Function in Type 1 Diabetes Mellitus (T1DM) (ASSET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918801
First Posted: June 11, 2009
Last Update Posted: November 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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.

Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study of Hippocampal Function in T1DM

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Enrollment: 91
Study Start Date: April 2007
Study Completion Date: October 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type 1 Diabetes Mellitus
Adolescents ages 13-18 with T1DM
Non Controls
Healthy adolescents ages 13-18 without T1DM

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young adults will be piloted in a sample of diabetic and non-diabetic adolescents ages 13-18.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918801


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Tamara G Hershey, PhD. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00918801     History of Changes
Other Study ID Numbers: 06-0786
First Submitted: June 8, 2009
First Posted: June 11, 2009
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This was a small pilot study and consent was not obtained to share data.

Keywords provided by Washington University School of Medicine:
T1DM
MRI

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases