Skip to main content
OpenTrials
Completed

NCT Number: NCT02747680

Cerebral Responses to Insulin Induced Hypoglycemia

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

The purpose of this study is to better understand the effect of low blood sugar (hypoglycemia) on blood flow and biochemistry in the brain. Hypoglycemia is a serious complication of diabetes treatments. It has been previously observed that hypoglycemia causes an increase in blood flow to certain parts of the brain, but it has been difficult to determine which parts of the brain specifically have an increase in blood flow. With new technology, it is now possible to determine the rate of blood flow in very small parts of the brain. The investigator expects that people with type 1 diabetes and hypoglycemia unawareness, poorly controlled diabetes, and normal subjects will have different rates of blood flow to different parts of the brain in response to hypoglycemia. Having a greater understanding of how the brain adapts to hypoglycemia may help us develop better ways to treat diabetes more safely.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

hypoglycemia (low blood sugar) in MRI

Other

hypoglycemia (low blood sugar) in MRI

Primary outcomes

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

    Time frame: baseline

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

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

    Time frame: baseline

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: 1018

Important dates

Study start
2004
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2016
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.