Phase 2
N=10
Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00786825 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Brain Glycogen Turnover Rate — 0.31; 0.28 mg/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- somatostatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Glycogen Turnover Rate |
0.31; 0.28 | — |
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.
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%
- 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
Data sourced from ClinicalTrials.gov (NCT00786825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.