Measurement of Glucose Metabolism in Humans: Effect of Recurrent Hypoglycemia on Hypothalamic GABA

Healthy Clinical Trial

— GABA  

Official title:

Measurement of Glucose Metabolism in Humans Using Magnetic Resonance at 7 Tesla: Effect of Recurrent Hypoglycemia on Hypothalamic GABA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829593
• Other study ID #: 1511M80568
• Status: Completed
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

You are invited to participate in a study designed to investigate the effects of diabetes mellitus, high and low glucose, and high blood insulin on the brain. You were selected as a possible participant because you fit into one of the following categories. a) you are either healthy and competent, are not pregnant and you have no known medical disease and therefore your glucose metabolism will be typical of a normal person, or b) you have diabetes.

Description:

Glucose is a major fuel for most organs in the human body, particularly the brain. How and where the body uses glucose is regulated by a number of hormones, for instance insulin and glucagon. In a number of diseases, in particular diabetes mellitus, the glucose supply to the brain may be different than normal, which may be a cause for reduced glucose awareness.

The purpose of this study is to determine the effects of altered glucose metabolism on the brain. For example, patients with long duration diabetes mellitus lose their ability to secrete the hormones necessary to protect them against hypoglycemia, which may be due to alterations in glucose availability to the human brain.

To measure these effects, we will use intravenous infusions of glucose and insulin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• 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%)

• age 18-65

• healthy controls

Exclusion Criteria:

• history of stroke, seizures, neurosurgical procedures, or arrhythmias

• use of drugs that can alter GABA 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.

Related Conditions & MeSH terms

• Healthy
• Hypoglycemia
• Type 1 Diabetes

Intervention

Other:
• hypoglycemia (low blood sugar) and MRI
hypoglycemia (low blood sugar) and 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	Change in Euglycemic GABA level in hypothalamus using MRI	MRI measurement of GABA in the hypothalamus	Baseline to 2 month