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

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

Sponsors

Lead Sponsor: University of Minnesota

Source 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.

Overall Status Recruiting
Start Date October 31, 2019
Completion Date May 2021
Primary Completion Date May 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Euglycemic GABA level in hypothalamus using MRI Baseline to 2 month
Enrollment 40
Condition
Intervention

Intervention Type: Other

Intervention Name: hypoglycemia (low blood sugar) and MRI

Description: hypoglycemia (low blood sugar) and MRI

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Anjali Kumar, PA-C

Phone: 612-301-7040

Email: [email protected]

Location
Facility: Status: Contact: Investigator: University of Minnesota Anjali Kumar, PA-C 612-301-7040 [email protected] Elizabeth Seaquist, MD Principal Investigator
Location Countries

United States

Verification Date

May 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: type 1 diabetes

Type: Experimental

Description: type 1 diabetes >5 years duration

Label: healthy controls

Type: Placebo Comparator

Acronym GABA
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov