| Trial ID: | L5199 |
| Source ID: | NCT01194479
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| Associated Drug: |
Formoterol
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| Title: |
Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01194479/results
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| Conditions: |
Type 1 Diabetes
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| Interventions: |
DRUG: Formoterol|OTHER: Placebo
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| Outcome Measures: |
Primary: Glucagon (pg/mL), Glucagon levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages., up to 120 minutes|Epinephrine (pg/mL), Epinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages, up to 120 minutes|Norepinephrine (pg/mL), Norepinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages, up to 120 minutes | Secondary: Blood Glucose Levels (Average), Blood glucose levels will be checked every 5 minutes during the 120 minute study session in order to maintain blood glucose levels in the normal and hypoglycemic range. Presented is the average of the collected values., Up to 120 minutes
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| Sponsor/Collaborators: |
Sponsor: Yale University | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
|
| Enrollment: |
14
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2010-08
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| Completion Date: |
2014-08
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| Results First Posted: |
2016-03-29
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| Last Update Posted: |
2016-03-29
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| Locations: |
Yale University School of Medicine, New Haven, Connecticut, 06520, United States
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| URL: |
https://clinicaltrials.gov/show/NCT01194479
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