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Antioxidant Treatment of Type 2 Diabetes
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), February 2009
First Received: January 23, 2008   Last Updated: February 17, 2009   History of Changes
Sponsored by: 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
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: Placebo
Drug: n-aceylcysteine
Phase 0

MedlinePlus related topics: Antioxidants Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Single Group Assignment

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Blood glucose [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2008
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo: Placebo Comparator Drug: Placebo
one capsule BID
antioxidant drug: Active Comparator
n-acetylcysteine
Drug: n-aceylcysteine
450 mgm BID

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Subjects with a known diagnosis of type 2 diabetes -

Exclusion Criteria: None, except known intolerance to n-acetylcysteine

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609102

Contacts
Contact: R Paul Robertson, MD 206-726-1210 rpr@pnri.org

Locations
United States, Washington
Pacific Northwest Research Institute Recruiting
Seattle, Washington, United States, 98122
Contact: R Paul Robertson, MD     206-726-1210     rpr@pnri.org    
Principal Investigator: R. Paul Robertson, MD            
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Pacific Northwest Research Institute ( R. Paul Robertson )
Study ID Numbers: Antioxidant trmt type 2, NIH R01 38325-19
Study First Received: January 23, 2008
Last Updated: February 17, 2009
ClinicalTrials.gov Identifier: NCT00609102     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Type 2 diabetes

Study placed in the following topic categories:
Antioxidants
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009