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

Not Applicable

Completed

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

• Registration Number: NCT02829593
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-12
• Study Start: 2019-10-31
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• well controlled type 1 diabetes (hemoglobin A1c <7.5%)
• age 18-65
• healthy controls

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
type 1 diabetes	hypoglycemia (low blood sugar) and MRI	type 1 diabetes \>5 years duration
healthy controls	hypoglycemia (low blood sugar) and MRI	-

Primary Outcome Measures

Name	Time	Method
Change in Euglycemic GABA level in hypothalamus using MRI	Baseline to 2 month	MRI measurement of GABA in the hypothalamus

Trial Locations

Locations (1)

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