Type 2 Diabetes Clinical Trial
Official title:
Effect of Anti-oxidants on Beta-cell Function in Humans
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.
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 initial 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 of NAC treatment on beta-cell function,
glucose tolerance and oxidative stress markers in persons with type 2 diabetes. Study
procedures will include a fasting urine sample and performance of a 2 hour 75 gram oral
glucose tolerance test at baseline, after 2 weeks on 600 mg twice daily NAC and again after
2 more weeks on 1200 mg NAC twice a day.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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