Antioxidant Treatment of Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

ClinicalTrials.gov Identifier:

NCT00609102

First received: January 23, 2008

Last updated: December 22, 2014

Last verified: December 2014

History of Changes

Tracking Information
First Received Date ^ICMJE	January 23, 2008
Last Updated Date	December 22, 2014
Start Date ^ICMJE	July 2008
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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	Phase 0
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Drug: Placebo one capsule BID Drug: n-aceylcysteine 450 mgm BID
Study Arm (s)	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
Enrollment ^ICMJE	44
Completion Date	September 2013
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
Gender	Both
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
Plan to Share Data	Not Provided
IPD Description	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
Information Provided By	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

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