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Antioxidant

Effect of the Anti-oxidant N-acetylcysteine on Beta-cell Function in Type 2 Diabetes

N/A
Waitlist Available
Led By Kristina Utzschneider, MD
Research Sponsored by Utzschneider, Kristina, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Type 2 diabetes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Type 2 Diabetes
  • Stress Oxidative

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fasting Urine F2 Alpha Isoprostane Levels
Secondary study objectives
Area Under the Curve for Glucose (AUCg)
Oral Disposition Index

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: N-acetylcysteine dose studyExperimental Treatment1 Intervention
Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylcysteine
FDA approved

Find a Location

Who is running the clinical trial?

Utzschneider, Kristina, M.D.Lead Sponsor
VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
224,771 Total Patients Enrolled
Kristina Utzschneider, MDPrincipal InvestigatorVA Puget Sound Health Care System
~1 spots leftby Jan 2026