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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02829593
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Healthy Other: hypoglycemia (low blood sugar) and MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 31, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

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




Primary Outcome Measures :
  1. Change in Euglycemic GABA level in hypothalamus using MRI [ Time Frame: Baseline to 2 month ]
    MRI measurement of GABA in the hypothalamus



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829593


Contacts
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Contact: Anjali Kumar, PA-C 612-301-7040 studydiabetes@umn.edu
Contact: Elizabeth Seaquist, MD 612-624-9176

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Anjali Kumar, PA-C    612-301-7040    studydiabetes@umn.edu   
Principal Investigator: Elizabeth Seaquist, MD         
Sponsors and Collaborators
University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02829593    
Other Study ID Numbers: 1511M80568
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases