NCT02829593

Brief Summary

You are invited to participate in a study designed to investigate the effects of diabetes mellitus, high and low glucose, and high blood insulin on the brain. You were selected as a possible participant because you fit into one of the following categories. a) you are either healthy and competent, are not pregnant and you have no known medical disease and therefore your glucose metabolism will be typical of a normal person, or b) you have diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

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

First Submitted

Initial submission to the registry

June 8, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
3.3 years until next milestone

Study Start

First participant enrolled

October 31, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

3.6 years

First QC Date

June 8, 2016

Last Update Submit

July 17, 2023

Conditions

Type 1 DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Change in Euglycemic GABA level in hypothalamus using MRI

    MRI measurement of GABA in the hypothalamus

    Baseline to 2 month

Study Arms (2)

type 1 diabetes

EXPERIMENTAL

type 1 diabetes \>5 years duration

Other: hypoglycemia (low blood sugar) and MRI

healthy controls

PLACEBO COMPARATOR
Other: hypoglycemia (low blood sugar) and MRI

Interventions

hypoglycemia (low blood sugar) and MRIOTHER

hypoglycemia (low blood sugar) and 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%)
  • age 18-65
  • healthy controls

You may not qualify if:

  • history of stroke, seizures, neurosurgical procedures, or arrhythmias
  • use of drugs that can alter GABA 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 Design

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

Study Record Dates

First Submitted

June 8, 2016

First Posted

July 12, 2016

Study Start

October 31, 2019

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations

US(1)