| Trial ID: | L7002 |
| Source ID: | NCT00678145
|
| Associated Drug: |
Naloxone
|
| Title: |
Mechanisms of Hypoglycemia Associated Autonomic Failure
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Hypoglycemia|Autonomic Failure
|
| Interventions: |
DRUG: naloxone|DIETARY_SUPPLEMENT: fructose|BEHAVIORAL: exercise|DRUG: Morphine sulfate|DRUG: Epinephrine
|
| Outcome Measures: |
Primary: Change in the counterregulatory responses to hypoglycemia compared to controls, Measurements of counterregulatory hormones will be measured throughout the study, Measured every 15 minutes at timepoints 0, 15, 30, 45...120 through study completion | Secondary: Symptom scores, Symptoms of hypoglycemia will be taken during the study, Measured every 15 minutes at timepoints 0, 15, 30, 45...120 through study completion
|
| Sponsor/Collaborators: |
Sponsor: Albert Einstein College of Medicine | Collaborators: National Institutes of Health (NIH)|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
116
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2008-03
|
| Completion Date: |
2022-08
|
| Results First Posted: |
|
| Last Update Posted: |
2021-01-14
|
| Locations: |
Albert Einstein College of Medicine / General Clinical Research Center, Bronx, New York, 10461, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00678145
|
