Back to resultsAntioxidant Treatment of Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
n-aceylcysteine
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes
Eligibility Criteria
Inclusion Criteria: Subjects with a known diagnosis of type 2 diabetes -
Exclusion Criteria: None, except known intolerance to n-acetylcysteine
-
Sites / Locations
- Pacific Northwest Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
antioxidant drug
Arm Description
n-acetylcysteine
Outcomes
Primary Outcome Measures
Blood glucose
Secondary Outcome Measures
HbA1c levels
Full Information
NCT ID
NCT00609102
First Posted
January 23, 2008
Last Updated
December 22, 2014
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00609102
Brief Title
Antioxidant Treatment of Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
Brief Summary
This study examines whether an antioxidant taken orally will improve glucose tolerance and insulin secretion in type 2 diabetic subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
antioxidant drug
Arm Type
Active Comparator
Arm Description
n-acetylcysteine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one capsule BID
Intervention Type
Drug
Intervention Name(s)
n-aceylcysteine
Intervention Description
450 mgm BID
Primary Outcome Measure Information:
Title
Blood glucose
Time Frame
3 months
Secondary Outcome Measure Information:
Title
HbA1c levels
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects with a known diagnosis of type 2 diabetes -
Exclusion Criteria: None, except known intolerance to n-acetylcysteine
-
Facility Information:
Facility Name
Pacific Northwest Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Antioxidant Treatment of Type 2 Diabetes
We'll reach out to this number within 24 hrs