Antioxidant Treatment of Type 2 Diabetes
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00609102 |
Recruitment Status
:
Completed
First Posted
: February 6, 2008
Last Update Posted
: December 24, 2014
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Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tracking Information | |||
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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 |
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 |
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 |
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Condition ICMJE | Type 2 Diabetes | ||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
44 | ||
Original Estimated Enrollment ICMJE |
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 |
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Sex/Gender |
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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 |
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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 |