NCT02747680

Brief Summary

This research study is designed to investigate the effect of hypoglycemia (low blood sugar) on blood flow to and biochemistry in the brain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

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

January 1, 2004

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

16.2 years

First QC Date

April 11, 2016

Last Update Submit

January 29, 2021

Conditions

Type 1 DiabetesHealthyHypoglycemia Unawareness

Keywords

type 1 diabeteshypoglycemia unawarenesshealthy control

Outcome Measures

Primary Outcomes (2)

  • Brain activation during euglycemia (normal blood sugar) using functional MRI

    Brain activation during euglycemia (normal blood sugar) using functional MRI

    baseline

  • Brain activation during hypoglycemia (low blood sugar) using functional MRI

    Brain activation during hypoglycemia (low blood sugar) using functional MRI

    baseline

Study Arms (2)

type 1 diabetes

OTHER

type 1 diabetes \>5 years duration Well controlled (a1c \<7.5%)

Other: hypoglycemia (low blood sugar) in MRI

healthy controls

OTHER

healthy controls

Other: hypoglycemia (low blood sugar) in MRI

Interventions

hypoglycemia (low blood sugar) in MRIOTHER

hypoglycemia (low blood sugar) in MRI

healthy controlstype 1 diabetes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • well controlled type 1 diabetes (hemoglobin A1C \<7.5%)
  • healthy controls

You may not qualify if:

  • History of stroke, seizures, neurosurgical procedures, or arrhythmias
  • Use of drugs that can alter GABA (gamma-aminobutyric acid) metabolism (such as benzodiazepines).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, 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

  • Elizabeth Seaquist, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 22, 2016

Study Start

January 1, 2004

Primary Completion

March 1, 2020

Study Completion

December 1, 2020

Last Updated

February 3, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)