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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Acetylcysteine; Hypoglycemic Agents; Insulin; N-monoacetylcystine

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