Measurement of Glucose Metabolism in Humans Using Magnetic Resonance at 7 Tesla: Effect of Recurrent Hypoglycemia on Hypothalamic GABA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in Euglycemic GABA level in hypothalamus using MRI
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
type 1 diabetes
type 1 diabetes >5 years duration
Intervention: hypoglycemia (low blood sugar) and MRI (Other)
healthy controls
Intervention: hypoglycemia (low blood sugar) and MRI (Other)
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
Secondary Outcomes
No secondary outcomes reported