Antioxidant Treatment of Type 2 Diabetes

December 22, 2014 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
This study examines whether an antioxidant taken orally will improve glucose tolerance and insulin secretion in type 2 diabetic subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98122
        • Pacific Northwest Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
one capsule BID
Active Comparator: antioxidant drug
n-acetylcysteine
Drug: n-aceylcysteine
450 mgm BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood glucose
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c levels
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antioxidant trmt type 2
  • NIH R01 38325-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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