Trial Outcomes & Findings for Effect of the Anti-oxidant N-acetylcysteine on Beta-cell Function in Type 2 Diabetes (NCT NCT01394510)

Results Overview

Change in fasting urine isoprostane levels at 4 weeks vs baseline as a marker of oxidative stress

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

4 weeks

Results posted on

2016-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	N-acetylcysteine Dose Study 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. N-acetylcysteine: 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.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N-acetylcysteine Dose Study n=13 Participants 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. N-acetylcysteine: 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.
Age, Continuous	53.9 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
body mass index	37.3 kg/m2 STANDARD_DEVIATION 10.1 • n=5 Participants
HbA1c	6.17 % STANDARD_DEVIATION 2.05 • n=5 Participants
metformin	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Change in urine F2 alpha isoprostanes/mg urine creatinine. Urine isoprostanes were only measured in a subset of participants due to lack of effect of the intervention on glucose tolerance.

Change in fasting urine isoprostane levels at 4 weeks vs baseline as a marker of oxidative stress

Outcome measures

Outcome measures
Measure	N-acetylcysteine Dose Study n=9 Participants 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. N-acetylcysteine: 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.
Fasting Urine F2 Alpha Isoprostane Levels	-0.089 ng/ml Standard Deviation 1.28

SECONDARY outcome

Timeframe: 4 weeks

Change in AUCg from 0-120 minutes during the oral glucose tolerance test at 4 weeks compared to baseline

Outcome measures

Outcome measures
Measure	N-acetylcysteine Dose Study n=13 Participants 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. N-acetylcysteine: 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.
Area Under the Curve for Glucose (AUCg)	-1011 mg/dl x 120 minutes Standard Deviation 10922

SECONDARY outcome

Timeframe: 4 weeks

The change in the oral disposition index defined was the change in the early insulin response divided by the change in glucose from 0-30 minutes during the oral glucose tolerance test divided by fasting insulin.

Outcome measures

Outcome measures
Measure	N-acetylcysteine Dose Study n=12 Participants 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. N-acetylcysteine: 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.
Oral Disposition Index	-0.08 mg/dl Standard Deviation 0.18

Adverse Events

N-acetylcysteine Dose Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristina Utzschneider, MD

VA Puget Sound Health Care System

Phone: 206-277-3568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place