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Study aim
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Measurement and comparison of the level of biochemical parameters, the level of vitamin D, the level of oxidative stress indicators, the level of expression of the Nlrp3 gene in the studied groups
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Design
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Clinical trial with control group, double-blind, randomized, phase 3-2 on 68 patients. Block-chain with Excel software was used for randomization.
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Settings and conduct
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First and after 8 weeks of intervention, from each individual, 10 cc of intravenous blood will be taken by a sampler at the hospital (morning blood sample with 12 hours of fasting) and will be divided into CBC vials (containing K2EDTA ) and clots. The samples are immediately transferred to laboratory and serum is separated and stored at freezing (-20. C) and CBC vials are kept at refrigerator (2-6. C).To perform biochemical tests (LDL, HDL, vitamin D and oxides) on the serum sample of the clot tube, and to perform genetic testing and measurement of HbA1C, CBC tube is used (LDL, HDL) tests with kits and The enzymatic method, HbA1C will be measured by Immunoturbidimetry technique and vitamin D will be measured with low luminescence.And for genetic testing, PCR real time technique is used, The status of oxidative stress is assessed with TAC kits by FRAP, Thiol group and MDA by spectrophotometry.
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Participants/Inclusion and exclusion criteria
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Inclusion :
The disease (diabetes) has been confirmed by a specialist.
At least 5 years have passed since the beginning of their diabetes
HbA1C is out of the normal range.
Age range 50-65 years
The desire to participate in the study
Exclusion :
Kidney and adrenal gland diseases, thyroid, liver,Systemic
Take multivitamins,corticosteroids
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Intervention groups
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Patients were randomly assigned to two groups (n = 34) to receive a dose of 50,000 units of vitamin D or placebo for 8 weeks each week.
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Main outcome variables
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HbA1C؛HDL؛ LDL ؛Nlrp3 ؛Oxidative stress status