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
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Type 1 Diabetes, Hypoglycemia Unawareness
In brief
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 the responses to experimental hypoglycemia on day two. 18 participants will be studied twice, 8 weeks apart. On each occasion they will undergo a 2 hour hypoglycemic clamp (target 50 mg/dl) in the morning and in the afternoon on day one and then again on the morning of day 2 and day 3. During the morning clamps, samples will be collected for later measurement of serum epinephrine levels, plasma and red blood cell NAC, cysteine, and glutathione concentrations and GSH/GSSG ratios (redox status), and participants will be asked to complete a hypoglycemia symptom questionnaire
Key facts
- Study ID
- NCT02206152
- Run by
- University of Minnesota
- People needed
- 22
- Starts
- 2015-02-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2020-01-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Healthy controls
- Age 18 - 65 years
- Baseline hemoglobin A1C <6.0%
You may not qualify if…
- 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
Where it is running
- University of Minnesota Department of Medicine, Division of Diabetes, Endocrinology and Metabolism — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.