1018: Cerebral Responses to Insulin Induced Hypoglycemia

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT02747680

Collaborator

(none)

266

Enrollment

Location

Arms

203

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Healthy Hypoglycemia Unawareness	Other: hypoglycemia (low blood sugar) in MRI	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

266 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Cerebral Responses to Insulin Induced Hypoglycemia

Actual Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Other: type 1 diabetes

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

Other: hypoglycemia (low blood sugar) in MRI

hypoglycemia (low blood sugar) in MRI

Other: healthy controls

healthy controls

Other: hypoglycemia (low blood sugar) in MRI

hypoglycemia (low blood sugar) in MRI

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.