Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla
Glycogen
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 5, 2008
CompletedFirst Posted
Study publicly available on registry
November 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
December 18, 2019
CompletedDecember 18, 2019
December 1, 2019
13 years
November 5, 2008
November 7, 2019
December 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain Glycogen Turnover Rate
1 month
Study Arms (2)
somatostatin
EXPERIMENTALType 1 diabetes and Hypoglycemia unawareness
2
NO INTERVENTIONHealthy control subjects
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Related Publications (1)
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.
PMID: 28911152DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elizabeth Seaquist, MD
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth R Seaquist, MD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2008
First Posted
November 6, 2008
Study Start
December 1, 2004
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
December 18, 2019
Results First Posted
December 18, 2019
Record last verified: 2019-12