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Antioxidant Treatment of Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00609102
First received: January 23, 2008
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
 Drug: Placebo
Drug: n-aceylcysteine
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 Comparator: Placebo Drug: Placebo
one capsule BID
Active Comparator: antioxidant drug
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

No publications provided

Responsible Party: R. Paul Robertson, Pacific Northwest Research Institute
ClinicalTrials.gov Identifier: NCT00609102     History of Changes
Other Study ID Numbers: Antioxidant trmt type 2, NIH R01 38325-19
Study First Received: January 23, 2008
Last Updated: March 15, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013