Phase 2 N=22 Randomized Triple-blind Prevention

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

Type 1 Diabetes · Hypoglycemia Unawareness

Bottom Line

View on ClinicalTrials.gov: NCT02206152 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcome: Primary: Difference in Epinephrine Secretion During the Morning Episodes of Hypoglycemia on Days One and Two Under the Two Treatment Conditions — 622.8; 867 ug/ml

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: N-acetyl cysteine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in Epinephrine Secretion During the Morning Episodes of Hypoglycemia on Days One and Two Under the Two Treatment Conditions	622.8; 867	—

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 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

Eligibility Criteria

Inclusion Criteria

Healthy controls
Age 18 - 65 years
Baseline hemoglobin A1C <6.0%

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02206152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.