Identifying the Brain Substrates of Hypoglycemia Unawareness in Type 1 Diabetes

Completed · Early Phase 1

Conditions studied: Hypoglycemia

In brief

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.

Key facts

Study ID

NCT02866435

Run by

University of Minnesota

People needed

27

Starts

2016-11-01

Expected to finish

2019-12-30

Last updated by the study team

2021-02-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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