ClinicalTrials.gov
ClinicalTrials.gov Menu

Antioxidant Treatment of Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00609102
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : December 24, 2014
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Placebo Drug: n-aceylcysteine Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : July 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
one capsule BID

Active Comparator: antioxidant drug
n-acetylcysteine
Drug: n-aceylcysteine
450 mgm BID




Primary Outcome Measures :
  1. Blood glucose [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. HbA1c levels [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609102


Locations
United States, Washington
Pacific Northwest Research Institute
Seattle, Washington, United States, 98122
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014

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

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