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Clinical Trials/NCT02829593
NCT02829593
Completed
Not Applicable

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

University of Minnesota1 site in 1 country34 target enrollmentOctober 31, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
University of Minnesota
Enrollment
34
Locations
1
Primary Endpoint
Change in Euglycemic GABA level in hypothalamus using MRI
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2019
End Date
May 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Euglycemic GABA level in hypothalamus using MRI

Time Frame: Baseline to 2 month

MRI measurement of GABA in the hypothalamus

Study Sites (1)

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