The purpose of this trial was to investigate an aerobic exercise training with vitamin C on serum creatine kinase levels in patients With type 2 diabetes.
Design
The Clinical trial was conducted with 3 intervention groups, the first, the second intervention and the control group. randomized, double blinded accepted.
Settings and conduct
This double-blind study was conducted for 8 weeks at Sistan and Baluchestan University. The intervention groups participated in the exercise training program and used vitamin C supplements. The control group did not receive any activity and did not receive supplementation. Blood samples were prepared before and after the exercise training program, and the serum was separated and frozen at - 26°C until analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Subject should be diabetes type 2 patients. their disease was diagnosed at least one year ago. having ability to stay in the protocol for 2 months.
Exclusion criteria: If they take insulin, If they have kidney disease.
Intervention groups
First intervention group: Aerobic training with placebo, exercises for 8 weeks, 3 sessions per week and 45 minutes each session. The main exercises, running with a maximum of 50-60% of maximum heart rate; the placebo was administered at a rate of (250 mg) of starch.
Second intervention group: Aerobic exercise plus vitamin C supplementation, in addition to the protocol, 2 hours before the exercise, they took vitamin C , daily (250 mg) of vitamin C, a product of the company (Oswah).
Control group that did not participate in any activity and did not take vitamin C supplements.
Main outcome variables
Creatine Kinase Serum Level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041097N1
Registration date:2018-11-12, 1397/08/21
Registration timing:retrospective
Last update:2018-11-12, 1397/08/21
Update count:0
Registration date
2018-11-12, 1397/08/21
Registrant information
Name
Reza Delavar
Name of organization / entity
The University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3113 2674
Email address
delavar@ped.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-29, 1397/02/09
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2018-04-29, 1397/02/09
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
2018-06-22, 1397/04/01
Scientific title
The effect of aerobic exercise and vitamin C intake on the CK serum level in diabetes type 2
Public title
The effect of aerobic exercise and vitamin C intakes on the serum level of creatine kinase in type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are sure to have type 2 diabetes
One year should be passed since their disease diagnosis
havinig Ability to attending the practice protocol for 2 months
Exclusion criteria:
if they take insulin.
if they have kidney disease.
Age
From 35 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Vitamin C (supplements) and starches(pelacebo) were similar in appearance and no apparent differences, any of group didn't have aware of the nature of the pill exercise-complementary and exercise-pelacebo group.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Medical Sciences Campus, Doctor Hassabi Sqaure
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
IR.ZAUMS.REC.1397.180
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
creatine kinase Serum level
Timepoint
Measurement of creatine kinase at the beginning of the study (2 and half hours before the training) and 24 hours after the last exercise session
Method of measurement
kit ( CK-NAC)EC2.7.3.2
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: Aerobic training group with placebo, exercises for 8 weeks, 3 sessions each week and each session for 45 minutes under the supervision of the researcher. The training program included 5 minutes warm-up (soft running, hand and foot comb and gestural movements), 35 minutes of main training included running with a maximum intensity of 50-60% of maximum heart rate and finally 5 minutes of cooing and return to baseline, placebo It was also prescribed (250 mg) of starch each day for two months.
Category
Placebo
2
Description
Second intervention group: Aerobic exercise group plus vitamin C intake, , consumed vitamin C twice a day for two months each day,2 hours before the exercise, they took vitamin C, 250 mg of vitamin C (a product of the company) (Oswah ) And approved by the Ministry of Health.exercises for 8 weeks, 3 sessions each week and each session for 45 minutes under the supervision of the researcher. The training program included 5 minutes warm-up (soft running, hand and foot comb and gestural movements), 35 minutes of main training included running with a maximum intensity of 50-60% of maximum heart rate and finally 5 minutes of cooing and return to baseline.
Category
Treatment - Drugs
3
Description
Control group: The subjects did not exercise during the 8 weeks of training and did not receive any supplement.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Bou-Ali Hospital
Full name of responsible person
Ms. Fatemeh Pudineh
Street address
Amir Al-Momenin Street, Bu'ali Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 8101
Email
boali@zamus.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University Of Sistan and Baluchestan
Full name of responsible person
Dor Mohammad. Kordi Tamandani. Ph.D
Street address
Central Organization of the University of Sistan and Baluchestan, University Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷۴۵۸۴۵
Phone
+98 54 3344 6251
Email
web@its.usb.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 Sistan and Baluchestan
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 Sistan and Baluchestan
Full name of responsible person
Reza Delavar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Daneshgah 25., Daneshgah Street., Sistan and Baluchestan University
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 2674
Fax
Email
delavar@ped.usb.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Sistan and Baluchestan
Full name of responsible person
Reza Delavar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Daneshgah 25., Daneshgah Street., Sistan and Baluchestan University
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 2674
Fax
Email
delavar@ped.usb.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University Of Sistan and Baluchestan
Full name of responsible person
Mahla Mahdavi far
Position
Student
Latest degree
Master
Other areas of specialty/work
Exersice Physiology
Street address
No.20, Hirmand 13 street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9819615196
Phone
+98 54 3323 2368
Email
m.mahdavi7214@yahoo.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
Yes - There is 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
Related Information to main outcome is possible for sharing
When the data will become available and for how long
Access is available 5 months after the results are printed
To whom data/document is available
Researchers at academia and industry
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document