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Cerebral Responses to Insulin Induced Hypoglycemia (1018)

Primary Purpose

Type 1 Diabetes, Healthy, Hypoglycemia Unawareness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hypoglycemia (low blood sugar) in MRI
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 1 Diabetes focused on measuring type 1 diabetes, hypoglycemia unawareness, healthy control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • well controlled type 1 diabetes (hemoglobin A1C <7.5%)
  • healthy controls

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

type 1 diabetes

healthy controls

Arm Description

type 1 diabetes >5 years duration Well controlled (a1c <7.5%)

healthy controls

Outcomes

Primary Outcome Measures

Brain activation during euglycemia (normal blood sugar) using functional MRI
Brain activation during euglycemia (normal blood sugar) using functional MRI
Brain activation during hypoglycemia (low blood sugar) using functional MRI
Brain activation during hypoglycemia (low blood sugar) using functional MRI

Secondary Outcome Measures

Full Information

First Posted
April 11, 2016
Last Updated
January 29, 2021
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02747680
Brief Title
Cerebral Responses to Insulin Induced Hypoglycemia
Acronym
1018
Official Title
Cerebral Responses to Insulin Induced Hypoglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2004 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Healthy, Hypoglycemia Unawareness
Keywords
type 1 diabetes, hypoglycemia unawareness, healthy control

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
type 1 diabetes
Arm Type
Other
Arm Description
type 1 diabetes >5 years duration Well controlled (a1c <7.5%)
Arm Title
healthy controls
Arm Type
Other
Arm Description
healthy controls
Intervention Type
Other
Intervention Name(s)
hypoglycemia (low blood sugar) in MRI
Intervention Description
hypoglycemia (low blood sugar) in MRI
Primary Outcome Measure Information:
Title
Brain activation during euglycemia (normal blood sugar) using functional MRI
Description
Brain activation during euglycemia (normal blood sugar) using functional MRI
Time Frame
baseline
Title
Brain activation during hypoglycemia (low blood sugar) using functional MRI
Description
Brain activation during hypoglycemia (low blood sugar) using functional MRI
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: well controlled type 1 diabetes (hemoglobin A1C <7.5%) healthy controls Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Seaquist, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cerebral Responses to Insulin Induced Hypoglycemia

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