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Hippocampal Metabolism and Function in Patients With Type 1 Diabetes

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.
 
ClinicalTrials.gov Identifier: NCT01852968
Recruitment Status : Active, not recruiting
First Posted : May 14, 2013
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The hippocampus is an area of brain which plays an essential role in learning and memory processing and is thought to be particularly vulnerable to effects of hypoglycemia (low blood glucose). The goal of this project is to examine hippocampal neurochemistry and metabolism and identify how diabetes and recurrent hypoglycemia alter the hippocampus.

Condition or disease
Hypoglycemia Diabetes Mellitus

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hippocampal Metabolism and Function in Patients With Type 1 Diabetes
Study Start Date : May 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with type 1 diabetes

Hippocampal neurochemistry and metabolism will examined in Patients with type 1 diabetes using magnetic resonance spectroscopy.

Patients with type 1 diabetes will also undergo neurocognitive testing to assess hippocampal function

healthy controls

Hippocampal neurochemistry and metabolism will be examined in healthy controls using magnetic resonance spectroscopy.

Healthy controls will also undergo neurocognitive testing to assess hippocampal function




Primary Outcome Measures :
  1. alterations in hippocampal glucose transport kinetics [ Time Frame: data will be acquired at the time of experiment. ]
    Hippocampal glucose transport kinetics will be examined using magnetic resonance spectroscopy


Secondary Outcome Measures :
  1. hippocampal function [ Time Frame: data will be collected on day of experiment ]
    Subjects will undergo neurocognitive testing with the California Verbal Learning Test - Second Edition (CVLT-II)and subtests from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS: Story Memory (immediate and delayed), Digit Span, and Coding.

  2. alterations in hippocampal neurochemistry [ Time Frame: data will be acquired at the time of experiment ]
    Hippocampal neurochemical profile will be examined using magnetic resonance spectroscopy


Biospecimen Retention:   Samples Without DNA
blood smaple will be drawn measurement of blood glucose, HgbA1C, insulin and hormone levels


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
University of Minnesota Endocrine Clinic, univeristy of Minnesota community and a registry of volunteers maintained by the investigators.
Criteria

Inclusion Criteria:

diagnosis of type 1 diabetes, hemoglobin A1C <9%. Alternatively, subject should be a healthy control.

Exclusion Criteria:

Exclusion criteria for both groups of subjects include history of stroke, seizures, neurosurgical procedures, or arrhythmias, and use of drugs that can alter glucose metabolism (other than insulin for the patients with diabetes). Subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs. and the absence of metallic substances in their body.


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): NCT01852968


Locations
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United States, Minnesota
Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Amir Moheet, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01852968    
Other Study ID Numbers: 1301M26901
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by University of Minnesota:
hypoglycemia
hypoglycemia unawareness
type 1 diabetes, hippocampus
glucose transport
cognitive dysfunction
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases