| Trial ID: | L5732 |
| Source ID: | NCT02206152
|
| Associated Drug: |
N-Acetyl Cysteine
|
| Title: |
A Randomized Double Blinded Study to Examine the Use of N-acetyl Cysteine for the Prevention and Treatment of HAAF in Patients With Type 1 Diabetes
|
| Acronym: |
NAC for HAAF
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02206152/results
|
| Conditions: |
Type 1 Diabetes|Hypoglycemia Unawareness
|
| Interventions: |
DRUG: N-acetyl cysteine|DRUG: Placebo
|
| Outcome Measures: |
Primary: Difference in Epinephrine Secretion During the Morning Episodes of Hypoglycemia on Days One and Two Under the Two Treatment Conditions, Epinephrine secretion during hypoglycemia is assessed by collecting blood samples for measurement of epinephrine concentrations at baseline and every 15 minutes during the period of hypoglycemia (starting at point where blood glucose is first \< 55 mg/dl) in the clamp studies done in the mornings of days 1 and 2 of both parts 1 and 2. ., 8-10 weeks |
|
| Sponsor/Collaborators: |
Sponsor: University of Minnesota
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2015-02
|
| Completion Date: |
2017-12
|
| Results First Posted: |
2020-01-31
|
| Last Update Posted: |
2020-01-31
|
| Locations: |
University of Minnesota Department of Medicine, Division of Diabetes, Endocrinology and Metabolism, Minneapolis, Minnesota, 55455, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02206152
|
