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

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT02829593
Collaborator
(none)
40
1
2
43
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: hypoglycemia (low blood sugar) and MRI
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Measurement of Glucose Metabolism in Humans Using Magnetic Resonance at 7 Tesla: Effect of Recurrent Hypoglycemia on Hypothalamic GABA
Actual Study Start Date :
Oct 31, 2019
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: type 1 diabetes

type 1 diabetes >5 years duration

Other: hypoglycemia (low blood sugar) and MRI
hypoglycemia (low blood sugar) and MRI

Placebo Comparator: healthy controls

Other: hypoglycemia (low blood sugar) and MRI
hypoglycemia (low blood sugar) and MRI

Outcome Measures

Primary Outcome Measures

  1. Change in Euglycemic GABA level in hypothalamus using MRI [Baseline to 2 month]

    MRI measurement of GABA in the hypothalamus

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%)

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT02829593
Other Study ID Numbers:
  • 1511M80568
First Posted:
Jul 12, 2016
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2022