Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla (Glycogen)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
somatostatin
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Hypoglycemia unawareness
Eligibility Criteria
Inclusion Criteria:
- Age 18-65
- Healthy control
- Must be able to provide informed consent
- Type 1 diabetes with hypoglycemia unawareness with hemoglobin A1c < 7.5%
- Poorly controlled diabetics with hemoglobin A1c > 7.5%
- Subjects with hypoglycemia unawareness must report an inability to recognize at least some blood glucose values <58 mg/dL during the 3 months prior to the study.
Exclusion Criteria:
- Over 300 pounds
- Claustrophobic
- History of ischemic heart disease, arrhythmia, of seizure disorder
- Pregnant
- On medications known to alter blood flow or carbohydrate metabolism
- Have internally located pieces of metal
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
somatostatin
2
Arm Description
Type 1 diabetes and Hypoglycemia unawareness
Healthy control subjects
Outcomes
Primary Outcome Measures
Brain Glycogen Turnover Rate
Secondary Outcome Measures
Full Information
NCT ID
NCT00786825
First Posted
November 5, 2008
Last Updated
December 5, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT00786825
Brief Title
Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla
Acronym
Glycogen
Official Title
Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 2004 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The long-range goal of this project is to determine the effects of diabetes and the hypoglycemic consequences of intensive therapy on in vivo brain glucose metabolism in humans. We will measure brain glycogen turnover and content in normal controls and subjects with diabetes under conditions of modest hyper-and hypoglycemia.
Detailed Description
On the morning before the study subjects will report to the Clinical Research Center and will be asked to stay at the Clinical Research Center for up to 72 hours. You will be asked not to eat anything after midnight. Small plastic catheters will be placed in two veins in subjects arms for infusion of glucose and for measuring blood glucose levels every 15-30 minutes. While subjects are in the study they will continuously receive a small dose of glucose enriched with 13C label either through the catheter or by drinking a small amount of a sugar water solution every 15-60 minutes. Subjects will be asked to transfer to the Center for Magnetic Resonance Research every 6-8 hours (except at night) where they will be asked each time to conduct an MRI scan as follows: Subjects will be placed on the patient bed in the magnet room for one-to-two hours. A nurse will stay with the subject at all times during this study. During some of the scans subjects may be asked to perform a visual task such as watching a changing checkerboard pattern through a mirror placed in front of their eyes. After each scan subjects will receive a low carbohydrate meal for weight-maintenance.
Subjects may be asked to receive an infusion of glucose and/or insulin one-to-three times before and/or after the infusion of 13C-enriched glucose starts. During these infusions the subject's blood sugar will be maintained either higher or lower than normal levels for up to 3 hours. This will be done to assess the effect of hyper- or hypoglycemia on brain glycogen metabolism.
Subjects may also be asked several days prior to the study to report to the Clinical Research Center for a "mock" study to see if they are comfortable with the MRI scan and/or to test their body's response to either protocol (as described above, but carried out at the Clinical Research Center). If subjects would like to try the MRI procedure in advance, this test will not exceed 2 hours. If we need to test the subject's response to the infusion, this "pre-test" will involve only drawing blood and administering glucose and will be performed as described for either protocol above, but will last not more than 4 hours.
Magnetic resonance measurements will be performed in the magnet and are very similar to magnetic resonance imaging exams (MRI). Subjects will always have the possibility to signal when they feel claustrophobic and wish to be removed from the magnet. The magnetic resonance measurements will be associated with a regular clunking noise that subjects may initially find unpleasant. For their comfort they will be offered to wear ear plugs. During the measurements in the magnet subjects will be asked to lie still for most of the time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Hypoglycemia unawareness
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
somatostatin
Arm Type
Experimental
Arm Description
Type 1 diabetes and Hypoglycemia unawareness
Arm Title
2
Arm Type
No Intervention
Arm Description
Healthy control subjects
Intervention Type
Drug
Intervention Name(s)
somatostatin
Intervention Description
Somatostatin may be used to suppress endogenous insulin secretion
Primary Outcome Measure Information:
Title
Brain Glycogen Turnover Rate
Time Frame
1 month
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:
Age 18-65
Healthy control
Must be able to provide informed consent
Type 1 diabetes with hypoglycemia unawareness with hemoglobin A1c < 7.5%
Poorly controlled diabetics with hemoglobin A1c > 7.5%
Subjects with hypoglycemia unawareness must report an inability to recognize at least some blood glucose values <58 mg/dL during the 3 months prior to the study.
Exclusion Criteria:
Over 300 pounds
Claustrophobic
History of ischemic heart disease, arrhythmia, of seizure disorder
Pregnant
On medications known to alter blood flow or carbohydrate metabolism
Have internally located pieces of metal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth R 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
55414
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28911152
Citation
Seaquist ER, Moheet A, Kumar A, Deelchand DK, Terpstra M, Kubisiak K, Eberly LE, Henry PG, Joers JM, Oz G. Hypothalamic Glucose Transport in Humans During Experimentally Induced Hypoglycemia-Associated Autonomic Failure. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3571-3580. doi: 10.1210/jc.2017-00477.
Results Reference
derived
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Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla
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