Type 1 Diabetes1018NCT02747680
Cerebral Responses to Insulin Induced Hypoglycemia
A study testing hypoglycemia (low blood sugar) in MRI in people with Type 1 Diabetes and Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
This research study is designed to investigate the effect of hypoglycemia (low blood sugar) on blood flow to and biochemistry in the brain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Healthy, Hypoglycemia Unawareness
- What is being tested?
- hypoglycemia (low blood sugar) in MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- well controlled type 1 diabetes (hemoglobin A1C <7.5%)
- healthy controls
Who cannot join
- History of stroke, seizures, neurosurgical procedures, or arrhythmias
- Use of drugs that can alter GABA (gamma-aminobutyric acid) 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
This research study is designed to investigate the effect of hypoglycemia (low blood sugar) on blood flow to and biochemistry in the brain.
Read the detailed description
The purpose of this study is to better understand the effect of low blood sugar (hypoglycemia) on blood flow and biochemistry in the brain. Hypoglycemia is a serious complication of diabetes treatments. It has been previously observed that hypoglycemia causes an increase in blood flow to certain parts of the brain, but it has been difficult to determine which parts of the brain specifically have an increase in blood flow. With new technology, it is now possible to determine the rate of blood flow in very small parts of the brain. The investigator expects that people with type 1 diabetes and hypoglycemia unawareness, poorly controlled diabetes, and normal subjects will have different rates of blood flow to different parts of the brain in response to hypoglycemia. Having a greater understanding of how the brain adapts to hypoglycemia may help us develop better ways to treat diabetes more safely.
- Conditions
- Type 1 Diabetes, Healthy, Hypoglycemia Unawareness
- Being tested
- hypoglycemia (low blood sugar) in MRI
- Keywords
- type 1 diabetes, hypoglycemia unawareness, healthy control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoglycemia (low blood sugar) in MRIOther
hypoglycemia (low blood sugar) in MRI
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes | Other | type 1 diabetes >5 years duration Well controlled (a1c <7.5%) Receives: Other: hypoglycemia (low blood sugar) in MRI |
| healthy controls | Other | healthy controls Receives: Other: hypoglycemia (low blood sugar) in MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation during euglycemia (normal blood sugar) using functional MRI
Brain activation during euglycemia (normal blood sugar) using functional MRI
Measured: baseline
Brain activation during hypoglycemia (low blood sugar) using functional MRI
Brain activation during hypoglycemia (low blood sugar) using functional MRI
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJan 2004
- Primary completionMar 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Seaquist, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747680
- Sponsor's protocol ID
- 8597
- Acronym
- 1018
- Status last verified
- Jan 2021
- First submitted
- 11 Apr 2016
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Filip P, Canna A, Grohn H, Moheet AA, Kumar AF, Li X, Zhang Y, Eberly LE, Seaquist ER, Mangia S. Disrupted neurovascular-endocrine coupling in type 1 diabetes with impaired awareness of hypoglycemia. J Clin Invest. 2026 Feb 19;136(8):e199725. doi: 10.1172/JCI199725. eCollection 2026 Apr 15.
PubMed 41712301
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Responses to Insulin Induced Hypoglycemia
- ClinicalTrials.gov ID
- NCT02747680
- Acronym / sponsor ID
- 1018 / 8597
- Conditions
- Type 1 Diabetes, Healthy, Hypoglycemia Unawareness
- Keywords
- type 1 diabetes, hypoglycemia unawareness, healthy control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2004 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is designed to investigate the effect of hypoglycemia (low blood sugar) on blood flow to and biochemistry in the brain.
Detailed description
The purpose of this study is to better understand the effect of low blood sugar (hypoglycemia) on blood flow and biochemistry in the brain. Hypoglycemia is a serious complication of diabetes treatments. It has been previously observed that hypoglycemia causes an increase in blood flow to certain parts of the brain, but it has been difficult to determine which parts of the brain specifically have an increase in blood flow. With new technology, it is now possible to determine the rate of blood flow in very small parts of the brain. The investigator expects that people with type 1 diabetes and hypoglycemia unawareness, poorly controlled diabetes, and normal subjects will have different rates of blood flow to different parts of the brain in response to hypoglycemia. Having a greater understanding of how the brain adapts to hypoglycemia may help us develop better ways to treat diabetes more safely.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes | Other | Other: hypoglycemia (low blood sugar) in MRItype 1 diabetes >5 years duration Well controlled (a1c <7.5%) |
| healthy controls | Other | Other: hypoglycemia (low blood sugar) in MRIhealthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- well controlled type 1 diabetes (hemoglobin A1C <7.5%)
- healthy controls
Key exclusion criteria (3 listed)
- History of stroke, seizures, neurosurgical procedures, or arrhythmias
- Use of drugs that can alter GABA (gamma-aminobutyric acid) 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypoglycemia (low blood sugar) in MRIhypoglycemia (low blood sugar) in MRI | Other | healthy controls, type 1 diabetes |
Primary outcome
Brain activation during euglycemia (normal blood sugar) using functional MRI
Time frame: baseline
Brain activation during euglycemia (normal blood sugar) using functional MRI
Brain activation during hypoglycemia (low blood sugar) using functional MRI
Time frame: baseline
Brain activation during hypoglycemia (low blood sugar) using functional MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Derived from this study: PubMed 41712301Filip P, Canna A, Grohn H, Moheet AA, Kumar AF, Li X, Zhang Y, Eberly LE, Seaquist ER, Mangia S. Disrupted neurovascular-endocrine coupling in type 1 diabetes with impaired awareness of hypoglycemia. J Clin Invest. 2026 Feb 19;136(8):e199725. doi: 10.1172/JCI199725. eCollection 2026 Apr 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Seaquist, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypoglycemia (low blood sugar) in MRI in people with Type 1 Diabetes and Healthy, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activation during euglycemia (normal blood sugar) using functional MRI (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.