NCT01852968

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

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

First Submitted

Initial submission to the registry

April 12, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

4.5 years

First QC Date

April 12, 2013

Last Update Submit

December 13, 2021

Conditions

Keywords

hypoglycemiahypoglycemia unawarenesstype 1 diabetes, hippocampusglucose transportcognitive dysfunction

Outcome Measures

Primary Outcomes (1)

  • alterations in hippocampal glucose transport kinetics

    Hippocampal glucose transport kinetics will be examined using magnetic resonance spectroscopy

    data will be acquired at the time of experiment.

Secondary Outcomes (2)

  • hippocampal function

    data will be collected on day of experiment

  • alterations in hippocampal neurochemistry

    data will be acquired at the time of experiment

Study Arms (2)

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

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

University of Minnesota Endocrine Clinic, univeristy of Minnesota community and a registry of volunteers maintained by the investigators.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Science Institute and Center for Magnetic Resonance Research, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Bednarik P, Henry PG, Khowaja A, Rubin N, Kumar A, Deelchand D, Eberly LE, Seaquist E, Oz G, Moheet A. Hippocampal Neurochemical Profile and Glucose Transport Kinetics in Patients With Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Feb 1;105(2):479-91. doi: 10.1210/clinem/dgz062.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood smaple will be drawn measurement of blood glucose, HgbA1C, insulin and hormone levels

MeSH Terms

Conditions

HypoglycemiaDiabetes MellitusDiabetes Mellitus, Type 1Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Amir Moheet, MD

    University of Minnesota

    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

April 12, 2013

First Posted

May 14, 2013

Study Start

May 1, 2013

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

December 15, 2021

Record last verified: 2021-12

Locations