Status:
COMPLETED
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
Lead Sponsor:
University of Minnesota
Conditions:
Type 1 Diabetes
Hypoglycemia Unawareness
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single center, double blind randomized cross over design trial that will compare the impact of N-acetyl cysteine (200 mg) vs. saline infusion during experimental hypoglycemia on day one on t...
Detailed Description
This study will consist of a screening visit and two 2-day intervention visits separated by approximately 8 weeks. At the screening visit, informed consent will be obtained, a standardized form will ...
Eligibility Criteria
Inclusion
- Healthy controls
- Age 18 - 65 years
- Baseline hemoglobin A1C \<6.0%
Exclusion
- History of stroke, seizures (other than those related to hypoglycemia), arrhythmias, active cardiac disease (all of which could be associated with adverse cardiac or neurological events during hypoglycemia)
- Pregnancy or plan to become pregnant during the study period
- Diagnosis of asthma (increases risk of hypersensitivity reactions to NAC)
- Use of anti-oxidants or drugs that can alter glucose metabolism
- Concomitant medical problems that may prevent the subject from successfully completing the protocol
- Unwillingness to avoid exercise during the 7 days before each part of the study
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02206152
Start Date
February 1 2015
End Date
December 1 2017
Last Update
January 31 2020
Active Locations (1)
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1
University of Minnesota Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Minneapolis, Minnesota, United States, 55455