Effect of Aerobic training with resvin supplement on inflammatory markers and insulin resistance in women with type 2 diabetes mellitus
Design
pre-test and post-test design and controlled with a control group
Settings and conduct
24 women with type 2 diabetes in one of the diabetes centers of Isfahan are selected by available sampling method.
Then they are divided into three groups, experimental group one (resin supplementation) and experimental group two (supplementation with aerobic exercise).
Duration of 6 weeks and 3 training sessions per week. Each session is stored for 40-60 minutes with an intensity of 65-45% of the heart rate by running on a treadmill.
Subjects in experimental groups one and experimental two receive 400 mg of resin supplementation for 42 days.
Participants/Inclusion and exclusion criteria
Having type 2 diabetes
Age between 60 -45 years
Fasting blood sugar between 250-150 mg per deciliter
No diseases associated with type 2 diabetes
History of cardiovascular disease
High blood pressure
Complications of diabetes such as diabetic foot ulcers
Have a regular exercise program in the last 3 months
Intervention groups
control group : Pre-test -- post-test
Experimental group 1 : pre-test supplementation - post-test
Experimental group 2 : pre-test aerobic exercise supplementation aerobic exercise
Main outcome variables
Effect of Aerobic training with resvin supplement on inflammatory markers and insulin resistance in women with type 2 diabetes mellitus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191203045588N1
Registration date:2020-09-23, 1399/07/02
Registration timing:registered_while_recruiting
Last update:2020-09-23, 1399/07/02
Update count:0
Registration date
2020-09-23, 1399/07/02
Registrant information
Name
Ensieh Yazdkhasti
Name of organization / entity
The University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 44 3251 8396
Email address
yazdkhasti.e@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-19, 1399/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aerobic training with resvin supplement on inflammatory markers and insulin resistance in women with type 2 diabetes mellitus
Public title
Effect of Aerobic training with resvin supplement on type 2 diabetes mellitus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes
Age between 60 -45 years
Fasting blood sugar between 250-150 mg per deciliter
No diseases associated with type 2 diabetes
Exclusion criteria:
History of cardiovascular disease
High blood pressure
Complications of diabetes such as diabetic foot ulcers
Have a regular exercise program in the last 3 months
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 arak university of Medical Sciences
Street address
Arak, arak university of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2013-05-03, 1392/02/13
Ethics committee reference number
IR.ARAKMU.REC.1392.147.1
Health conditions studied
1
Description of health condition studied
دیابت نوع 2
ICD-10 code
ICD-10 code description
دیابت نوع 2
Primary outcomes
1
Description
Reactive protein c
Timepoint
Before intervention and after 6 weeks of intervention
Method of measurement
blood test
2
Description
Insulin
Timepoint
Before intervention and after 6 weeks of intervention
Method of measurement
blood test
3
Description
Interlukin 6
Timepoint
Before intervention and after 6 weeks of intervention
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Aerobic exercise group with supplementation (8 people), for 6 weeks, 3 sessions per week and each session with a duration of 10 - 5 minutes warm-up, 40-50 minutes of walking with an intensity of 65-45% of heart rate , walking on a treadmill and cool for 5-10 minutes
Category
Other
2
Description
Intervention group: The supplement group (8 people) consumed one 0.04 gram resveratrol capsule (named Resvin, manufactured by Geymonat, Italy) for 6 weeks.
Category
Other
3
Description
Control group: No supplements and exercises (8 people)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Diabetes Charity
Full name of responsible person
Ali Abtahi
Street address
Ave ahmadabad
City
Isfahan
Province
Isfehan
Postal code
9333333333
Phone
+98 31 3223 9330
Email
Diabetsngo@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of Arak
Full name of responsible person
Hooshang Yazdani
Street address
SHariaati
City
Arak
Province
Markazi
Postal code
9333333333
Phone
+98 86 3222 2222
Email
araku@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Arak
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
The University of Mohaghegh Ardabili
Full name of responsible person
Ensieh Yazdkhasti
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology sport
Street address
Daneshgah Ave, Ardabil
City
Ardabil
Province
Ardabil
Postal code
9333333333
Phone
+98 44 3251 8396
Fax
Email
yazdkhasti.e@uma.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Ensieh Yazdkhasti
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology sport
Street address
Daneshgah Ave, Ardabil
City
Ardabil
Province
Ardabil
Postal code
9333333333
Phone
+98 44 3251 8396
Fax
Email
yazdkhasti.e@uma.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Ensieh Yazdkhasti
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology sport
Street address
Daneshgah Ave, Ardabil
City
Ardabil
Province
Ardabil
Postal code
9333333333
Phone
+98 44 3251 8396
Fax
Email
yazdkhasti.e@uma.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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