Cerebral Responses to Insulin Induced Hypoglycemia

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Healthy; Hypoglycemia Unawareness
• Interventions: Other: hypoglycemia (low blood sugar) in MRI

• Registration Number: NCT02747680
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Primary Completion: 2020-03
• Study Completion: 2020-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy controls	hypoglycemia (low blood sugar) in MRI	healthy controls
type 1 diabetes	hypoglycemia (low blood sugar) in MRI	type 1 diabetes \>5 years duration Well controlled (a1c \<7.5%)

Primary Outcome Measures

Name	Time	Method
Brain activation during euglycemia (normal blood sugar) using functional MRI	baseline	Brain activation during euglycemia (normal blood sugar) using functional MRI
Brain activation during hypoglycemia (low blood sugar) using functional MRI	baseline	Brain activation during hypoglycemia (low blood sugar) using functional MRI

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States