NCT00609102

Brief Summary

This study examines whether an antioxidant taken orally will improve glucose tolerance and insulin secretion in type 2 diabetic subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for early_phase_1 type-2-diabetes

Timeline
Completed

Started Jul 2008

Longer than P75 for early_phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

5.2 years

First QC Date

January 23, 2008

Last Update Submit

December 22, 2014

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    3 months

Secondary Outcomes (1)

  • HbA1c levels

    3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

antioxidant drug

ACTIVE COMPARATOR

n-acetylcysteine

Drug: n-aceylcysteine

Interventions

PlaceboDRUG

one capsule BID

Placebo
n-aceylcysteineDRUG

450 mgm BID

antioxidant drug

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Northwest Research Institute

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 6, 2008

Study Start

July 1, 2008

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 24, 2014

Record last verified: 2014-12

Locations

US(1)