Protocol summary
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Study aim
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Determine the oral zinc supplementation effect on superoxide dismutase gene expression and enzyme activity, stress-oxidative index, in type 2 diabetic patients.
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Design
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double blind clinical trial, phase III, on 70 type 2 diabetic patients. Participants will be randomly divided to two groups, intervention(35) and control(35).
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Settings and conduct
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patient with type 2 diabetes, who referred to Diabetes and Metabolic Diseases Clinic of Endocrinology and Metabolism Research Institute. 7 mL blood samples will be taken from each participant after 12 hour fasting condition. In other words, we will allocate 2ml blood in EDTA tube for gene analysis and HbA1c assay, and 5ml in plain tube for biochemistry assays.Biochemical data will be evaluated and reported before and after the 8 weeks of supplementation for all patients at the end of study. In this study, all the participants, the primary researcher, health care providers, sample collectors, and those who prepare manuscript draft were blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: male/female with age 40-65, type 2 diabetes, Exclusion criteria: cigarette smoking, cancer, thyroid or gastrointestinal or renal disorders, antibiotics and vitamin.
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Intervention groups
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The case groups will take 25 mg the gluconate Zinc capsule (twice daily), and the control group will take Avicel capsule twice daily.
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Main outcome variables
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Superoxide dismutase gene expression, superoxide dismutase activity, Zinc, Fasting Blood Sugar, Hemoglobin A1c, Nitrotyrosine, Total antioxidant capacity
,Total oxidant capacity, Malondialdehyde, Insulin, Body mass index
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150831023838N1
Registration date:
2018-01-05, 1396/10/15
Registration timing:
prospective
Last update:
2018-03-25, 1397/01/05
Update count:
1
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Registration date
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2018-01-05, 1396/10/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-01-06, 1396/10/16
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Expected recruitment end date
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2018-03-21, 1397/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Study of oral zinc supplementation effect on the superoxide dismutase gene expression and enzyme activity, and oxidative stress index in overweight type 2 diabetic patients.
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Public title
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Study of oral zinc supplementation effect on type 2 diabetes
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Purpose
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Basic scienece
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Inclusion/Exclusion criteria
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Inclusion criteria:
Afflicted with type 2 diabetes mellitus
BMI= 25-30 kg/m2
HbA1c ≥7
Exclusion criteria:
Smoking
Taking diuretics
Taking antibiotics
Taking multivitamins containing zinc
Gastrointestinal disorders
Thyroid disorders
Cancer history
Renal disorders
Liver disorders
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Age
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From 40 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple-block randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, all the participants, the primary researcher, health care providers, sample collectors, and those who prepare manuscript draft were blinded.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-03-02, 1394/12/12
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Ethics committee reference number
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IR.TUMS.EMRI.REC.1395.00105
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes mellitus
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Gene expresion of Superoxide dismutase
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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Real time PCR
2
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Description
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Superoxide dismutase activity
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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ELISA
3
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Description
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Serum levels of Zinc
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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Atomic Absorption Spectroscopy
4
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Description
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Serum levels of Malondialdehyde
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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ELISA
5
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Description
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Serum levels of Total Antioxidant Capacity
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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ELISA
6
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Description
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Serum levels of Total Oxidant Capacity
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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ELISA
7
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Description
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Serum levels of Nitrotyrosine
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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ELISA
8
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Description
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Serum levels of Fasting Blood Suger
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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spectroscopy
9
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Description
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Glycated hemoglobin
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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High Efficiency Liquid Cgromotography (HPLC)
10
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Description
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Serum levels of Cholestrol
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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spectroscopy
11
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Description
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Serum levels of Triglycerid
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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spectroscopy
12
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Description
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Serum levels of Insulin
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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Electrochemiluminescence
13
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Description
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Height
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Timepoint
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Before the intervention
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Method of measurement
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Meter
14
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Description
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Weight
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Timepoint
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Before and 8 weeks after intervention
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Method of measurement
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Scales
Intervention groups
1
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Description
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Intervention group: One day will take, 2 capsules of zinc gluconate 25 mg for 60 days. These capsules are made by ALHAVI Company in Iran.
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Category
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Treatment - Drugs
2
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Description
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Control group: One day will take, 2 capsules of Avesil , for 60 days. These capsules are made by ALHAVI Company in Iran.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Endocrinology and metabolism research institute
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Proportion provided by this source
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63
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat Modares university faculty of medical sciences
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Proportion provided by this source
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30
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Article
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available