Determination of the effects of combined aerobic-resistance exercise training on levels of Chemerin and Omentin in men with type 2 diabetes
Design
Clinical trial with two groups (intervention and control), Parallel, Pragmatic, Randomized
Settings and conduct
This study will be conducted to evaluate the effects of combined aerobic-resistance exercise training on levels of Chemerin and Omentin in men with type 2 diabetes in the Diabetes Clinic of Vasey Hospital in Sabzevar. Patients will be randomly assigned to the intervention (combined aerobic-resistance exercise) and control group. The response to treatment is evaluated using Luminescence quantitative and ELISA methods for the study groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Lack of cardiovascular, musculoskeletal, and metabolic disorders limiting exercise, Lack of high blood pressure, Lack of regular exercise activity in the last 6 months, Not receiving insulin.
Exclusion Criteria: Inability to perform exercises, Having regular sports activities rather than research exercises.
Intervention groups
Intervention group: The training group will undergo combined aerobic-resistance exercise training with distinct intensity for 12 weeks, three sessions a week. Each training session will include 5 to 10 minutes of warm-up, 45 minutes of resistance training, 30 minutes of aerobic training, respectively.
Control group: control subjects also only perform their routine activities. In order to measure the biochemical variables, the blood sampling is performed after 12 hours of fasting and in two steps before the start of the training program and after 12 weeks. Subjects are asked to do no severe activity for two days prior to blood sampling.
Main outcome variables
Determine the levels of Chemerin and Omentin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181006041252N11
Registration date:2019-05-21, 1398/02/31
Registration timing:retrospective
Last update:2019-05-21, 1398/02/31
Update count:0
Registration date
2019-05-21, 1398/02/31
Registrant information
Name
Mohammad Sahebkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8337
Email address
sahebkarm@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-13, 1394/01/24
Expected recruitment end date
2015-06-14, 1394/03/24
Actual recruitment start date
2015-04-13, 1394/01/24
Actual recruitment end date
2015-06-14, 1394/03/24
Trial completion date
2015-06-14, 1394/03/24
Scientific title
Investigating the effects of combined aerobic-resistance exercise training on levels of Chemerin and Omentin in men with type 2 diabetes
Public title
Effects of combined aerobic-resistance exercise training on levels of Chemerin and Omentin in men with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of cardiovascular, musculoskeletal, and metabolic disorders limiting exercise
Lack of high blood pressure
Lack of regular exercise activity in the last 6 months
Not receiving insulin
Exclusion criteria:
Inability to perform exercises
Having regular sports activities rather than research exercises
Age
From 30 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
24
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted based on a permutation block by a statistical consultant using random allocation software and the output sequences A and B are available to the researcher, Accordingly, 6 blocks were allocated to patients, in each block, 2 from A treatment group, 2 from the B treatment group were placed. Eventually, after completing the blocks group A was trained with combined aerobic-resistance exercise, Group B does not receive any special treatment (control). First, we determine all sixsome modes in which two individuals are assigned to group A and two to group B. Then we assign one of the digits 1 to 6 to each of the sixsome combinations (which includes thirty-six modes). In the next step, we must randomly select 6 blocks of six and write their combinations in succession. For this we have to make 6 samplings with replacement from a six-member community; 6 times, choose a random number between 1 and 6 and this process will continue until the end of the sampling and the difference between the two groups will not exceed a maximum of two (half the size of the block).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2015-04-13, 1394/01/24
Ethics committee reference number
IR.MEDSAB.REC.1394.2
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Determine the levels of chemerin
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the start of the training program
Method of measurement
Use of Luminescence quantitative and ELISA methods
2
Description
Determine the level of omentin
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the start of the training program
Method of measurement
Use of Luminescence quantitative and ELISA methods
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The training group will undergo combined aerobic-resistance exercise training with distinct intensity for 12 weeks, three sessions a week. Each training session will include 5 to 10 minutes of warm-up, 45 minutes of resistance training, 30 minutes of aerobic training, respectively. In order to measure the biochemical variables, the blood sampling is performed after 12 hours of fasting and in two steps before the start of the training program and after 12 weeks. Subjects are asked to do no severe activity for two days prior to blood sampling.
Category
Treatment - Other
2
Description
Control group: control subjects also only perform their routine activities. In order to measure the biochemical variables, the blood sampling is performed after 12 hours of fasting and in two steps before the start of the training program and after 12 weeks. Subjects are asked to do no severe activity for two days prior to blood sampling.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Mehdi Zarei
Street address
Vasei Hospital, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1014
Email
Zarei.m8716@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sabzevar University of Medical Sciences
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
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Mehdi Zarei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
Zarei.m8716@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Mehdi Zarei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
Zarei.m8716@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Mehdi Zarei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
Zarei.m8716@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available