Protocol summary

Study aim
The study aimed to investigate the anti-inflammatory effects of vitamin D and resistance training in men with type 2 diabetes mellitus and vitamin D deficiency.
Design
Forty eight men were randomly divided into four groups including; vitamin D supplements and resistance training group, resistance training group, vitamin D supplementation group, or control group. The trial had a control group, a community-based, factorial double-blinded groups, and simple randomization using random numbers table.
Settings and conduct
This research was conducted in Ardabil city and among type 2 diabetic patients referred to the Diabetes Association of the city. Before and after 12 weeks, blood samples were taken to examine the inflammatory factors of the subjects. Bleeding was done until the end of the intervention for researchers, biochemical laboratory technicians, statisticians, subjects and all testers except one person.
Participants/Inclusion and exclusion criteria
The participants were forty-eight inactive people aged 40-65 who had symptoms of diabetes. Inclusion Criteria: The fasting blood glucose level was higher than 126 mg/dL, HbA1c was less than 9%, and the symptoms of vitamin D deficiency with 25 hydroxyvitamin D were less than 20 ng/ml. Exclusion criteria: People with kidney, cardiovascular, liver and other chronic diseases, as well as patients with a history of regular exercise with a history of supplementation with vitamin D and calcium
Intervention groups
Intervention group 1: Vitamin D and resistance training, intervention group 2: resistance training, intervention group 3: vitamin D supplementation group and intervention group 4: control group
Main outcome variables
Main outcome variables In this study, systemic inflammatory indexes included some interleukins and C-reactive protein. The effect of 12 weeks of exercise training and vitamin D supplements on them was investigated.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190204042621N1
Registration date: 2019-02-27, 1397/12/08
Registration timing: retrospective

Last update: 2019-02-27, 1397/12/08
Update count: 0
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
khalid mohamadzadeh salamat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3328 8661
Email address
kh.mohamadzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-10, 1396/12/19
Expected recruitment end date
2018-06-12, 1397/03/22
Actual recruitment start date
2018-03-10, 1396/12/19
Actual recruitment end date
2018-06-12, 1397/03/22
Trial completion date
2018-08-23, 1397/06/01
Scientific title
Anti-Inflammatory Effects of Vitamin D and Resistance Training in Men with Type 2 Diabetes mellitus and Vitamin D Deficiency
Public title
Effect of exercise training and vitamin D on diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 35 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 55
Actual sample size reached: 48
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Azad University of Medical Sciences
Street address
Saheli and Azadegan interaction-Imam Khomeini Educational Center
City
Ardabil
Province
Ardabil
Postal code
5615731567
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.AIAU.REC.1396.271

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
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

2

Description
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

3

Description
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

Secondary outcomes

1

Description
loss weight
Timepoint
Before intervention and 12 weeks after that
Method of measurement
With Scale

Intervention groups

1

Description
Intervention group 1: Resistance training
Category
Rehabilitation

2

Description
Intervention group 2: Vitamin D intake
Category
Treatment - Other

3

Description
Intervention group 3: Resistance training + vitamin D
Category
Treatment - Other

4

Description
Control group: Control without intervention + Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ardabil University of Medical Sciences-Ardabil Diabetes Association
Full name of responsible person
Shiva Asbaghian
Street address
Intersection of Saheli St. and Azadegan Highway, Imam Khomeini Hospital
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 2225 1401
Fax
+98 45 2225 1401
Email
ArdabilDAss@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Sanandaj Branch
Full name of responsible person
Dr Abdollah refaiee
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
ict@iausdj.ac.ir
Web page address
http://www.iausdj.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Sanandaj Branch
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Khalid Mohamadzadeh Salamat
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
kh.mohamadzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Khalid Mohamadzadeh Salamat
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
kh.mohamadzadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Khalid Mohamadzadeh Salamat
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
kh.mohamadzadeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Exercise training and supplementation protocols and Initial consequences
When the data will become available and for how long
2019-2020
To whom data/document is available
All
Under which criteria data/document could be used
Use of data and results to improve the status of diabetic patients
From where data/document is obtainable
Islamic Azad University of Sanandaj website and the Center for Clinical Trials Registration (IRCT)
What processes are involved for a request to access data/document
Refer to the above sites
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