The aim was to investigate the effect of milk consumption after resistance training (RT) on glycemic control and irisin response in type 2 diabetic (T2D) men.
Design
Randomized Control Trial
Settings and conduct
The training was conducted in a gym in Qazvin.
Participants/Inclusion and exclusion criteria
36 type 2 diabetic men
selection criteria: 6 months history of type 2 diabetes
Exclusion criteria: lack of any diabetic complications (neuropathy, nephropathy, retinopathy), not being under insulin treatment, no regular participation in sport activities over the last six months, no change in anti-glycemic medication over the last two months, no weight loss over 5% at last two months, no extreme obesity (BMI<40), no consumption of hormonal drugs or hormone-therapy such as thyroid, etc., no consumption of alcohol beverages, cigarette, and other drugs.
Intervention groups
Resistance Training Group
Resistance and milk training group
Effect of milk consumption after resistance training on glycemic control and irisin response in type 2 diabetic men
Public title
Exercise and Milk Consumption in Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diabetics men
age between 45-60 year
Exclusion criteria:
diabetic complications (neuropathy, nephropathy, retinopathy)
under insulin treatment
participation in regular sport activities over the last six months
change in oral anti-glycemic medication over the last two months
weight changes over 5% at last two months
extreme obesity (BMI<40)
consumption of hormonal drugs or hormone-therapy such as thyroid, etc.
consumption of alcohol beverages, cigarette, and other drugs
Age
From 45 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, individualized randomization using random number table
Each person was given a code ranging from 1 to 36 and the person who was unaware of the codes was randomly assigned 12 codes. The first 12 codes were assigned to the intervention group 1, the next 12 codes to the intervention group 2 and the next 12 codes to the control group.
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 Qazvin University of Medical Sciences
Street address
Department of Sports Sciences, Semnan University, Semnan, Iran
City
Qazvin
Province
Qazvin
Postal code
35131-19111
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.QUMS.REC.1397.221
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11.6
ICD-10 code description
Type 2 diabetes mellitus with other specified complications
Primary outcomes
1
Description
fasting blood sugar
Timepoint
Before and after the study
Method of measurement
blood sampling
Secondary outcomes
1
Description
Muscle strength and circumference
Timepoint
before and after study
Method of measurement
A maximum repetition and measurement with tape measure
Intervention groups
1
Description
Intervention group 1: resistance training. The group performed 8 weeks of resistance training with a maximum of 12 repetitions for 3 days per week. Each movement was performed in 3 sets, each lasting 45 minutes. The movement consisted of 7 gestures. Breast Press, Foot Press, Shoulder Press, Ab Crunch, Seated Cable Rows, Leg Extension, Lat Pulldown
Category
Lifestyle
2
Description
Intervention group 2: resistance training and milk intake. This group performed Intervention group 1 training and consumed 500 ml of low-fat milk immediately after each training session.
Category
N/A
3
Description
control group: without training and milk.The group continued its normal life without any exercise and changes to its regular diet.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghazvin diabetes association
Full name of responsible person
Mohsen Ebrahimi
Street address
Department of Sports Sciences, Semnan University, Semnan, Iran
City
semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3338 2184
Email
mebrahimi@semnan.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University
Full name of responsible person
Seyfolah Saedodin
Street address
Research Deputy, Central Organization, Semnan University, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3153 5810
Email
Research.VC@semnan.ac.ir
Grant name
Grant code / Reference number
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
Mohsen Ebrahimi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Department of Sports Sciences, Semnan University, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3338 2184
Email
mebrahimi@semnan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Mohsen Ebrahimi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Department of Sports Sciences, Semnan University, Semnan, Iran
City
Semnan University
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3338 2184
Email
mebrahimi@semnan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Mohsen Ebrahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Department of Sports Sciences, Semnan University, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3338 2184
Fax
Email
mebrahimi@semnan.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available