| Trial ID: | L4912 |
| Source ID: | NCT01672255
|
| Associated Drug: |
Fluoxetine
|
| Title: |
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes|Hypoglycemia Associated Autonomic Failure
|
| Interventions: |
DRUG: Fluoxetine|DRUG: Placebo control
|
| Outcome Measures: |
Primary: Change in Catecholamines, This change in catecholamines will be compared to another 90 minute experimental period after 8 weeks administration of SSRI or placebo., During 90 minute experimental period |
|
| Sponsor/Collaborators: |
Sponsor: University of Maryland, Baltimore | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-10
|
| Completion Date: |
2026-12
|
| Results First Posted: |
|
| Last Update Posted: |
2024-09-05
|
| Locations: |
University of Maryland, Baltimore, Baltimore, Maryland, 21201, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01672255
|
