Cerebral Responses to Insulin Induced Hypoglycemia (1018)

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University of Minnesota (UMN)

Status

Completed

Conditions

Healthy
Type 1 Diabetes
Hypoglycemia Unawareness

Treatments

Other: hypoglycemia (low blood sugar) in MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT02747680
8597 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment

266 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

266 participants in 2 patient groups

type 1 diabetes
Other group
Description:
type 1 diabetes >5 years duration Well controlled (a1c <7.5%)
Treatment:
Other: hypoglycemia (low blood sugar) in MRI
healthy controls
Other group
Description:
healthy controls
Treatment:
Other: hypoglycemia (low blood sugar) in MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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