Expired Study
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Seattle, Washington 98122


Purpose:

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


Criteria:

Inclusion Criteria: Subjects with a known diagnosis of type 2 diabetes - Exclusion Criteria: None, except known intolerance to n-acetylcysteine -


Study is Available At:


Original ID:

Antioxidant trmt type 2


NCT ID:

NCT00609102


Secondary ID:

NIH R01 38325-19


Study Acronym:


Brief Title:

Antioxidant Treatment of Type 2 Diabetes


Official Title:


Overall Status:

Completed


Study Phase:

Phase 0


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

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


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Single


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

44


Enrollment Type:

Actual


Study Dates

Start Date:July 2008
Completion Date:September 2013
Completion Type:Actual
Primary Completion Date:September 2013
Primary Completion Type:Actual
Verification Date:December 2014
Last Changed Date:December 22, 2014
First Received Date:January 23, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:HbA1c levels
Time Frame:3 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Blood glucose
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:one capsule BID
Arm Name:Placebo
Intervention Type:Drug
Name:n-aceylcysteine
Description:450 mgm BID
Arm Name:antioxidant drug

Study Arms

Study Arm Type:Active Comparator
Arm Name:antioxidant drug
Description:n-acetylcysteine
Study Arm Type:Placebo Comparator
Arm Name:Placebo

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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