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

Primary Purpose

Type 1 Diabetes, Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hypoglycemia (low blood sugar) and MRI
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

type 1 diabetes

healthy controls

Arm Description

type 1 diabetes >5 years duration

Outcomes

Primary Outcome Measures

Change in Euglycemic GABA level in hypothalamus using MRI
MRI measurement of GABA in the hypothalamus

Secondary Outcome Measures

Full Information

First Posted
June 8, 2016
Last Updated
July 17, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02829593
Brief Title
Measurement of Glucose Metabolism in Humans: Effect of Recurrent Hypoglycemia on Hypothalamic GABA
Acronym
GABA
Official Title
Measurement of Glucose Metabolism in Humans Using Magnetic Resonance at 7 Tesla: Effect of Recurrent Hypoglycemia on Hypothalamic GABA
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Healthy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
type 1 diabetes
Arm Type
Experimental
Arm Description
type 1 diabetes >5 years duration
Arm Title
healthy controls
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
hypoglycemia (low blood sugar) and MRI
Intervention Description
hypoglycemia (low blood sugar) and MRI
Primary Outcome Measure Information:
Title
Change in Euglycemic GABA level in hypothalamus using MRI
Description
MRI measurement of GABA in the hypothalamus
Time Frame
Baseline to 2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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

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