Identifying the Brain Substrates of Hypoglycemia Unawareness in Type 1 Diabetes



Status:Recruiting
Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:10/13/2018
Start Date:November 2016
End Date:December 2019
Contact:Anjali F Kumar, PA-C
Email:kumar045@umn.edu
Phone:612-624-0470

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The purpose of this study is to investigate how the brain responds to low blood glucose in
non-diabetic individuals. The ultimate goal is to understand the brain substrates of
hypoglycemia unawareness, a condition that can occur in patients with type1 diabetes
undergoing insulin treatment.In the present study, the investigators focus on differences
between two groups of non-diabetic subjects: one group who experienced two episodes of
hypoglycemia the day prior to the study (and supposedly developed some level of unawareness
to hypoglycemia), and one group who did not. In this study, a 3 tesla MRI scanner is used to
acquire brain images. The imaging system is identical to the ones used in hospitals.

Hypoglycemia, also called low blood glucose or low blood sugar, occurs when blood glucose
drops below normal levels. When blood glucose starts to drop, the body reacts to this drop,
trying to restore the blood glucose level. Symptoms of hypoglycemia are usually easily
recognized. Hypoglycemia can be treated quickly and easily by eating or drinking a small
amount of glucose-rich food. However some people with long history of diabetes can have an
impaired response to hypoglycemia and therefore don't recognize the symptoms of hypoglycemia,
condition called hypoglycemia unawareness. If not treated hypoglycemia can get worse and
cause confusion, clumsiness, fainting etc. Currently, it is not fully understood which brain
areas are involved in sensing the drop of glucose levels. Absence of such knowledge is a
critical barrier to the design and monitoring of effective intervention strategies to avoid
and/or reverse hypoglycemia unawareness. The purpose of this study is to investigate how the
brain responds to low blood glucose in non-diabetic individuals. Specific focus is given to
differences between two groups of non-diabetic subjects: one group who experienced two
episodes of hypoglycemia the day prior to the study (and therefore supposedly developed some
level of unawareness to hypoglycemia), and one group who did not.

Inclusion Criteria:

Participants will be included in the study, if they

- are non-diabetic

- are evaluated as not contraindicated (based on exclusion criteria)

- are age (within 5 years), gender, and body mass index (within 4 kg/m2) matched to
patients with type 1 diabetes who have participated to a similar study which involved
only the second part (day 2) of the current protocol.

Exclusion Criteria:

Participants will be excluded from the study, if they

- have any type of bio‐implant activated by mechanical, electronic, or magnetic means
(e.g. cochlear implants, pacemakers, neurostimulators, bio stimulators, electronic
infusion pumps)

- have any type of ferromagnetic bio‐implant that could potentially be displaced or
damaged, such as aneurysm clips, metallic skull plates, etc

- have any retained metal in their body, either from a medical procedure or an injury

- have history of stroke, seizures, neurosurgical procedures, or arrhythmias

- are pregnant

- are currently using medication that can alter glucose metabolism or brain perfusion

- weight more than 300lbs (limit for MRI scanner)

- have concomitant medical problems that may prevent them from successfully completing
the protocol

- lack capacity to consent
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-624-0470
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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