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IRCT20190204042621N1 IRCT 2019-02-27 Islamic Azad University, Sanandaj Branch Effect of exercise training and vitamin D on diabetic patients Anti-Inflammatory Effects of Vitamin D and Resistance Training in Men with Type 2 Diabetes mellitus and Vitamin D Deficiency 2018-03-10 anticipated 55 Complete https://irct.ir/trial/37351 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: Depending on the number of subjects and groups, it was decided to divide the groups by simple random method and in an individually style. In that, random numbers table were used to divide the equal groups. Random sequences were also used to allocation concealment groups from non-transparent, sealed envelopes. The randomization process was carried out by researchers and two assistants, but the researchers did not know the type of each group. Specifically, vitamin and placebo groups were blamed for researchers, Blinding description: lab technicians and expert statisticians did not know the type of intervention of any of the groups. Subjects and researchers also blinded to vitamin and placebo groups. Capsules containing vitamins and placebo were similar and only one of the practitioner's help was able to relate to the content of vitamin and placebo, and supplement giving was done by this person. He had a list of people in the groups that provided them with the capsules. This blindness continued until the end of the intervention and analysis of the data. N/A Type 2 diabetes. Intervention 1: Intervention group 1: Resistance training. Intervention 2: Intervention group 2: Vitamin D intake. Intervention 3: Intervention group 3: Resistance training + vitamin D. Intervention 4: Control group: Control without intervention + Placebo. Yes - There is a plan to make this available What will be shared: Exercise training and supplementation protocols and Initial consequences When: 2019-2020 To whom: All Conditions: Use of data and results to improve the status of diabetic patients Where to obtain: Islamic Azad University of Sanandaj website and the Center for Clinical Trials Registration (IRCT) How to obtain: Refer to the above sites Comments:
public Khalid Mohamadzadeh Salamat
Pasdaran
Sanandaj Iran (Islamic Republic of) 6616935391 +98 87 3328 8661 kh.mohamadzadeh@gmail.com Islamic Azad University scientific Khalid Mohamadzadeh Salamat
Pasdaran
Sanandaj Iran (Islamic Republic of) 6616935391 +98 87 3328 8661 kh.mohamadzadeh@gmail.com Islamic Azad University Iran (Islamic Republic of) Having type 2 diabetes for at least 2 years Fasting blood glucose more than 126 mg / dL HbA1c less than 9% Vitamin D3 level less than 20 ng / ml 35 years 60 years Male History of using medications such as insulin, calcium and vitamin D History of kidney, cardiovascular, liver and other diseases Age under 35 and over 60 Having a regular exercise activity one year before the study E11 Type 2 diabetes mellitus Rehabilitation Treatment - Other Treatment - Other Placebo Intervention group 1: Resistance training Intervention group 2: Vitamin D intake Intervention group 3: Resistance training + vitamin D Control group: Control without intervention + Placebo Tumor Necrosis Factor-alpha (TNF-α). Timepoint: Before the intervention and 12 week after. Method of measurement: Serum levels were measured by the ELISA method and by biochemical kits, Diaclone , France. Interleukin-6 (IL-6). Timepoint: Before the intervention and 12 week after. Method of measurement: Serum levels were measured by the ELISA method and by biochemical kits, Diaclone , France. C-Reactive Protein. Timepoint: Before the intervention and 12 week after. Method of measurement: Serum levels were measured by the ELISA method and by biochemical kits, Roche Diagnostics Company, Swiss. Loss weight. Timepoint: Before intervention and 12 weeks after that. Method of measurement: With Scale. Islamic Azad University, Sanandaj Branch Approved 2018-01-28 Ethics committee of Azad University of Medical Sciences Saheli and Azadegan interaction-Imam Khomeini Educational Center Ardabil Ardabil Iran (Islamic Republic of)