Protocol summary

Study aim
Effect of eight weeks resistance training and ginger supplementation on oxidative stress indices in type 2 diabetic patients
Design
Clinical trial, The group (placebo, ginger supplement, supplemented exercise, placebo training), community-based (type 2 diabetes association in Shiraz), and pragmatic, with parallel groups, blinded (then from a person who did not know the codes, It was asked to randomly list numbers from 1 to 44. The first 11 subjects in the placebo group, 11 in the supplement group, 11 in the training with supplement group, and the last 11 in the training with placebo group were placed. Randomized;
Settings and conduct
Sport protocol for 8 weeks under the supervision of researcher and co-workers in Shiraz University and in Shiraz. Physical Fitness and Fitness Hall Resistive training was carried out both on-the-spot and on-line. None of the participants in the project, such as students, supervisor professors, consultant professors, and laboratory personnel, did not know how to educate the intervention of different groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Arthralgia and bone softness, bone fractures, smokers, and alcoholics, if used antioxidant supplements (including ginger, vitamin C, vitamin E), history of resistance exercise in one year Exclusion criteria: Sudden Diseases; Digestive Problems Caused by Supplements and Physical Problems
Intervention groups
Subjects were divided into four groups: ginger (8 subjects), placebo (8), resistance training with placebo (8), and resistance training with ginger (8)
Main outcome variables
In general, the purpose of this exercise was to evaluate oxidative stress index and antioxidant index in patients with type 2 diabetes mellitus in Shiraz.

General information

Reason for update
Acronym
دیابت نوع دو
IRCT registration information
IRCT registration number: IRCT20181205041856N1
Registration date: 2019-02-09, 1397/11/20
Registration timing: retrospective

Last update: 2019-02-09, 1397/11/20
Update count: 0
Registration date
2019-02-09, 1397/11/20
Registrant information
Name
Hamzeh Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4068
Email address
hamzeh.gh88@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-03, 1395/02/14
Expected recruitment end date
2016-07-04, 1395/04/14
Actual recruitment start date
2016-04-02, 1395/01/14
Actual recruitment end date
2016-05-02, 1395/02/13
Trial completion date
2016-09-20, 1395/06/30
Scientific title
Study of the effect of eight week resistance training with ginger supplementation on oxidative stress and antioxidant index in type 2 diabetes
Public title
The effect of resistance training and ginger supplementation on the index of superoxide dismutase, malondialdehyde and body composition of type 2 diabetes mellitus.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
People between the ages of 40 and 60 year t least 3 years have passed Male gender Member of Diabetes Association of Shiraz Diagnosis of Type 2 diabetes by a specialist Informed consent It has a body composition of 25-29.9 kg / m 2
Exclusion criteria:
Not a professional athlete Not taking antioxidant supplements, selenium, zinc, beta-carotene, omega-3 ... At least 3 months before the start of the study. Not participating in another research project Absence of respiratory, metabolic, cardiovascular diseases Do not change the oral drug lowering blood glucose No Diabetic Complications No smoking and alcohol Disease associated with softness and bone
Age
From 40 years old to 60 years old
Gender
Male
Phase
1
Groups that have been masked
  • Participant
Sample size
Target sample size: 44
Actual sample size reached: 44
More than 1 sample in each individual
Actual sample size in each individual: 11
11
Randomization (investigator's opinion)
Randomized
Randomization description
First, each of the subjects was coded by one person who was not involved in the research (classmates). Then, from someone who did not know the codes, they were asked to randomly list numbers from 1 to 44. The first 11 first placebo groups, 11 in the supplementation group, 11 in the supplementation and exercise groupe. The last 11 people were placed in the exercise with placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants in the study (subjects) were aware of the need to consider the use of ginger supplements in this study, but were not aware of the contents of the capsules (placebo or ginger) that they consumed. The main investigators (student, supervisor, and counselor) have not been aware of which capsule (placebo or ginger) have been consumed before the end of the research. The laboratory personnel who have been responsible for sampling and measuring variables have not been informed about which subject the capsule (placebo or ginger) has consumed.
Placebo
Used
Assignment
Parallel
Other design features
Resistance training will be performed in a stationary and circular manner. The movements include leg press, chest press, pull-down triceps, knee extention, row seated, forward arm. It has biceps curl and abdominal crunch

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz, Zand Avenue, opposite the Palestine Street, Central Building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2016-01-25, 1394/11/05
Ethics committee reference number
این پژوهش توسط کمیته اخلاق دانشگاه علوم پزشکی شیراز با کد 38515/04/9/پ/94/ص تصویب شده و در پایگاه کارآزمایی‎های بالینی ایران با شماره IR.SUMS.REC.1394.178 ثبت شده است.

Health conditions studied

1

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

Primary outcomes

1

Description
Malondialdehyde
Timepoint
Two months (from May 15, 2016 to July 15, 2016)
Method of measurement
The concentrations Malondialdehyde by spectrophotometer method

2

Description
superoxidedismutase
Timepoint
month two (from May 15, 2016 to July 15, 2016)
Method of measurement
Serum supraxid dismutase was calculated by ELISA reader.

Secondary outcomes

1

Description
body composition
Timepoint
month two (Two months (from May 15 to July 15, 2016))
Method of measurement
body composition using a caliper device was calculated

2

Description
SOD
Timepoint
Two months from May 15, 2016 to July 15, 2016
Method of measurement
The concentration of superoxide dismutase index was calculated by ELISA method

3

Description
MDA
Timepoint
Two months from May 15, 2016 to July 15, 2016
Method of measurement
Concentration of MDA by spectrophotometer and Thiobarbituric Acid Test

Intervention groups

1

Description
Control group: placebo Group
Category
Placebo

2

Description
Intervention group: Resistance training group with placebo
Category
Other

3

Description
Intervention group: Resistance training with ginger
Category
Other

4

Description
Intervention group: Ginger Group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Mellitus Association of Shahid Motahari Clinic
Full name of responsible person
Masoumeh Akhlaghi
Street address
Shiraz, Zand Avenue, opposite the Palestine Street, Central Building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3233 7855
Fax
+98 71 3235 9847
Email
president@sums.ac.ir
Web page address
https://www.sums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
semnan university
Full name of responsible person
seyed mohsen avandi
Street address
Semnan - Facing Sokan Park - Campus No. 1 - Central Organization of Semnan University
City
semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3365 4100
Fax
+98 23 3332 1005
Email
president@semnan.ac.ir
Web page address
https://human.semnan.ac.ir/index.aspx?fkeyid=&siteid=25&pageid=3709
Grant name
Grant Assistant Professor Seyyed Mohsen Avadi
Grant code / Reference number
12
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
semnan university
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
semnan university
Full name of responsible person
seyed mohsen avandi
Position
assistant professor of semnan university
Latest degree
Ph.D.
Other areas of specialty/work
exercise training
Street address
Semnan - Opposite Sokan Park - Campus No. 1 - Faculty of Humanities
City
Semnan
Province
Semnan
Postal code
19111-35131
Phone
+98 23 3365 4100
Fax
+98 23 3332 1005
Email
president@semnan.ac.ir
Web page address
https://human.semnan.ac.ir/index.aspx?fkeyid=&siteid=25&pageid=3709

Person responsible for scientific inquiries

Contact
Name of organization / entity
semnan university
Full name of responsible person
Seyed mohsen avandi
Position
Associate professor of semnan university
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Semnan - Opposite Sokan Park - Campus No. 1 - Faculty of Humanities
City
semnan
Province
Semnan
Postal code
19111-35131
Phone
+98 23 3365 4100
Fax
+98 23 3332 1005
Email
president@semnan.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
semnan university
Full name of responsible person
hamzeh mohammadi
Position
student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Semnan - Opposite Sokan Park - Campus No. 1 - Faculty of Humanities
City
semnan
Province
Semnan
Postal code
19111-35131
Phone
+98 23 3365 4100
Fax
+98 23 3332 1005
Email
hamzeh.gh88@yahoo.com
Web page address
https://human.semnan.ac.ir/index.aspx?fkeyid=&siteid=25&pageid=3709

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The protocol was performed for two weeks in both pretest and post-test. You can access the data from Semnan University; Faculty of Humanities; Assistant Professor Seyyed Mohsen Adandi
When the data will become available and for how long
2015 and 2020
To whom data/document is available
seyed mohsen avandi and hamzeh mohammadi
Under which criteria data/document could be used
To help educate the community and students who want to continue the protocol
From where data/document is obtainable
University of Semnan - Faculty of Humanities - Department of Sport Physiology - Dr. Seyyed Mohsen Avadi
What processes are involved for a request to access data/document
If requested, ask for one week to two weeks by email: hamzeh.gh88@yahoo.com
Comments
If you have not received an email, please call 09135603693.
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