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NCT02747680 Clinical Trial

Cerebral Responses to Insulin Induced Hypoglycemia

Healthy Clinical Trial

— 1018  

Official title:
Cerebral Responses to Insulin Induced Hypoglycemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02747680
Other study ID # 8597
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2004
Est. completion date December 2020

Study information
Verified date January 2021
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 266
Est. completion date December 2020
Est. primary completion date March 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• hypoglycemia (low blood sugar) in MRI
hypoglycemia (low blood sugar) in MRI

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Brain activation during euglycemia (normal blood sugar) using functional MRI Brain activation during euglycemia (normal blood sugar) using functional MRI baseline
Primary Brain activation during hypoglycemia (low blood sugar) using functional MRI Brain activation during hypoglycemia (low blood sugar) using functional MRI baseline
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