Antioxidant Treatment of Type 2 Diabetes

Tracking Information
First Submitted Date ICMJE	January 23, 2008
First Posted Date ICMJE	February 6, 2008
Last Update Posted Date	December 24, 2014
Study Start Date ICMJE	July 2008
Actual Primary Completion Date	September 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 23, 2008)	Blood glucose [ Time Frame: 3 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00609102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 23, 2008)	HbA1c levels [ Time Frame: 3 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Antioxidant Treatment of Type 2 Diabetes
Official Title ICMJE	Not Provided
Brief Summary	This study examines whether an antioxidant taken orally will improve glucose tolerance and insulin secretion in type 2 diabetic subjects.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Early Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Type 2 Diabetes
Intervention ICMJE	Drug: Placebo one capsule BID; Drug: n-aceylcysteine 450 mgm BID
Study Arms	Placebo Comparator: Placebo Intervention: Drug: Placebo; Active Comparator: antioxidant drug n-acetylcysteine Intervention: Drug: n-aceylcysteine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 22, 2014)	44
Original Estimated Enrollment ICMJE; (submitted: January 23, 2008)	90
Actual Study Completion Date	September 2013
Actual Primary Completion Date	September 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Subjects with a known diagnosis of type 2 diabetes - Exclusion Criteria: None, except known intolerance to n-acetylcysteine
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00609102
Other Study ID Numbers ICMJE	Antioxidant trmt type 2; NIH R01 38325-19
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	R. Paul Robertson, Pacific Northwest Research Institute
Study Sponsor ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	December 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP