Cerebral Responses to Insulin Induced Hypoglycemia

NCT ID: NCT02747680

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Type 1 Diabetes; Healthy; Hypoglycemia Unawareness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

type 1 diabetes

type 1 diabetes \>5 years duration Well controlled (a1c \<7.5%)

Group Type: OTHER

hypoglycemia (low blood sugar) in MRI

Intervention Type: OTHER

hypoglycemia (low blood sugar) in MRI

healthy controls

healthy controls

Group Type: OTHER

hypoglycemia (low blood sugar) in MRI

Intervention Type: OTHER

hypoglycemia (low blood sugar) in MRI

Interventions

hypoglycemia (low blood sugar) in MRI

hypoglycemia (low blood sugar) in MRI

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Seaquist, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

8597

Identifier Type: -

Identifier Source: org_study_id