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Antioxidant Treatment of Type 2 Diabetes
This study has been completed.
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
| 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 |
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 Blind (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 | ||
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* 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 | ||
| 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 |
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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 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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