CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
N-acetylcysteinedrug
Likely dose
N-acetylcysteine 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01394510
NCT01394510N/ACompleted

Effect of Anti-oxidants on Beta-cell Function in Humans

Utzschneider, Kristina, M.D.·interventional·Posted Jul 14, 2011·Updated Jun 17, 2016

In Brief

A clinical study evaluating N-acetylcysteine for Type 2 Diabetes and Oxidative Stress. Completed, enrolled 13 participants across 1 site.

Detailed Summary

Insulin is secreted by cells in the pancreas called beta-cells. Beta-cell dysfunction is a critical feature of type 2 diabetes (T2DM). High glucose levels can exacerbate beta-cell dysfunction with oxidative stress proposed as a major mediator of this "glucotoxic" effect. High glucose levels have also been shown to contribute to vascular dysfunction and inflammation and these adverse responses decreased with the use of antioxidants. The hypothesis is that antioxidants improve beta-cell function in individuals with elevated glucose levels by decreasing oxidative stress. In this study the investigators will specifically test whether the antioxidant N-acetylcysteine (NAC) can improve beta-cell function in individuals with type 2 diabetes by decreasing oxidative stress. This study will be a dose finding study to determine the tolerability of 600 mg versus 1200 mg twice a day of NAC and the effects on beta-cell function, glucose tolerance and oxidative stress markers in persons with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2011
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2014
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.0 years ago

Interventions

N-acetylcysteinedrug

600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks.