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
  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:


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
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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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Zinc
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 23, 2014