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Cerebral Responses to Insulin Induced Hypoglycemia

Cerebral Responses to Insulin Induced Hypoglycemia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02747680
Acronym
1018
Enrollment
266
Registered
2016-04-22
Start date
2004-01-31
Completion date
2020-12-31
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Hypoglycemia Unawareness, Type 1 Diabetes

Keywords

type 1 diabetes, hypoglycemia unawareness, healthy control

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.

Detailed 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.

Interventions

OTHERhypoglycemia (low blood sugar) in MRI

hypoglycemia (low blood sugar) in MRI

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Brain activation during euglycemia (normal blood sugar) using functional MRIbaselineBrain activation during euglycemia (normal blood sugar) using functional MRI
Brain activation during hypoglycemia (low blood sugar) using functional MRIbaselineBrain activation during hypoglycemia (low blood sugar) using functional MRI

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026