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Zinc Supplementation in Type 2 Diabetics

This study has been completed.
Sponsor:
Collaborator:
National University, Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01309620
First received: March 2, 2011
Last updated: March 3, 2011
Last verified: March 2011
History of Changes
  Purpose

Zinc supplementation reduces the extent of oxidative damage and improves vascular indices in type 2 diabetics


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
 Dietary Supplement: Zinc gluconate
Dietary Supplement: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Zinc Supplementation Reduce the Extent of Oxidative Stress Damage in Diabetics? A Randomised Placebo-controlled Study.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Markers of oxidative damage [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Isoprostanes, HETEs, cholesterol oxidation products, neuroprostanes, allantoin


Secondary Outcome Measures:
  • Vascular indices [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Augmentation index and aortic pressure


Enrollment: 40
Study Start Date: January 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo, Twice Daily
Other Name: Placebo
Experimental: Zinc supplement Dietary Supplement: Zinc gluconate
Zinc gluconate (GNC, USA), 100 mg twice daily
Other Names:
  • Zinc gluconate (GNC, USA)
  • Zinc
  • Zinc supplementation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Subjects aged 21 years and above Subjects with type 2 diabetes mellitus

Exclusion criteria:

Those who consumed over-the counter or prescription drugs, vitamin/mineral supplements or traditional Chinese remedies Those who suffered acute infection less than 30-days prior to the start of the study Those who had been diagnosed with active neuropsychiatric disease or hematological diseases Those who had hemoglobin less than 10g/dL Those who had previous use of narcotic drugs or regular alcohol intake in excess of 14 units per week.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309620

Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
Investigators
Principal Investigator: Raymond CS Seet, MBBS National University Hospital, Singapore
  More Information

No publications provided by National University Hospital, Singapore

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Seet Chee Seong, Raymond, National University of Singapore
ClinicalTrials.gov Identifier: NCT01309620     History of Changes
Other Study ID Numbers: DSRB A/08/045
Study First Received: March 2, 2011
Last Updated: March 3, 2011
Health Authority: Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
zinc, oxidative stress, vascular indices, type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Zinc
 Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013