The purpose of this study was to evaluate the simultaneous effects of aerobic training and vitamin D supplementation on blood glucose, insulin, glycosylated hemoglobin, body mass index, waist to hip ratio, and body fat percent in type 2 diabetic patients.
Design
Subjects will be divided into 4 groups of 15 including: Experimental group 1 (perform 12 weeks of aerobic training with vitamin D supplementation), Experimental group 2 (perform 12 weeks of aerobic training with placebo), Experimental group 3 (take vitamin D supplement without any exercise training), and the control group (without any exercise training and without vitamin D supplementation). Two intervention groups that taking vitamin D, they have receive 2 servings of vitamin D (each serving 5000 IU). Experimental groups (1 and 2) will perform progressive aerobic training for 12 weeks, 3 sessions per week, and approximately 70 minutes per session. Before and after 12-week intervention, the measurements of the research variables will be done.
Settings and conduct
Training place (for 12-week) is in the exercise physiology lab of University of Kurdistan.
Participants/Inclusion and exclusion criteria
Participants are women with type 2 diabetes who have no history of vitamin D consumption, as well as have no history of regular training in the past 6 months. These people should have no chronic disease other than diabetes. Indeed, their medicine to control diabetes is metformin tabletes.
Intervention groups
Aerobic training group
Vitamin D supplementation group
Main outcome variables
Glucose; Insulin; Glycosylated hemoglobin; Nuclear factor of kappa; Waist to hip ratio; Body mass index; Body fat percent
General information
Reason for update
Acronym
تمرین، ویتامین D و دیلبت
IRCT registration information
IRCT registration number:IRCT20140512017675N2
Registration date:2019-08-20, 1398/05/29
Registration timing:prospective
Last update:2019-08-20, 1398/05/29
Update count:0
Registration date
2019-08-20, 1398/05/29
Registrant information
Name
Dariush Sheikholeslami-Vatani
Name of organization / entity
University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 912 225 0724
Email address
d.vatani@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-24, 1398/06/02
Expected recruitment end date
2019-11-23, 1398/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aerobic training with vitamin D supplementation on insulin, Glycosylated hemoglobin, nuclear factor of kappa in type 2 diabetic women
Public title
The effect of aerobic training and vitamin D supplementation on diabetes indices
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having a female sex
Having type 2 diabetes
No history of vitamin D supplementation in the past 6 months
No record of regular exercise training in the past 6 months
No having other chronic diseases other than diabetes
Use of metformin to control of diabetes
Exclusion criteria:
Insulin injection as a drug for the control of diabetes type 2
Being over 60 years old
Age
From 35 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
From the list of women with type 2 diabetes at the diabetes association of Sanandaj city, and among those who meet to internal criteria, 60 people were selected in a simple random sampling, then randomly assigned to one of 4 groups. Randomization will be as a lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Subjects and phydifsicians were unaware of how individuals were divided into different groups (taking vitamin D supplement or placebo).
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University research ethics committee of University of Kurdistan
Street address
University of Kurdistan, Pasdaran Blvd, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66196-14741
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.UOK.REC.1398.026
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
Blood sugar and insulin levels in type 2 diabetic patients
Timepoint
Before the intervention, and after 12-week of vitamin D supplementation as well as aerobic training
Method of measurement
By human serum kits, and caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Doing 12-week of aerobic training along with Vitamin D3 supplementation. Subjects in this group perform 12 weeks of aerobic training, 3 sessions per week, and each session about 70 minutes. Indeed, they receive Vitamin D3 supplement as 3 doses of 5000 IU per week, after breakfast (at non-training days) and with enough water.
Category
Other
2
Description
Intervention group 2: Doing 12-week of aerobic training along with placebo intake. Subjects in this group perform 12 weeks of aerobic training, 3 sessions per week, and each session about 70 minutes. Moreover, they receive 3 times a week maltodextrin capsules (containing 2 grams) as placebo and in similar manner with the first intervention group.
Category
Other
3
Description
Intervention group 3: Vitamin D3 supplementation without exercise training. They receive Vitamin D3 supplement in interval days as 3 doses of 5000 IU per week, after breakfast and with enough water.
Category
Other
4
Description
Control group: Subjects in this group will have no any regular exercise training or Vitamin D3 intake during the 12-week course.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Kurdistan
Full name of responsible person
Dariush Sheikholeslami-Vatani
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
66196-14741
Phone
+98 87 3366 4600
Email
d.vatani@uok.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Kurdistan
Full name of responsible person
kayomars Karami
Street address
University of Kurdistan, Pasdaran Blvd, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
kkarami@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Kurdistan
Proportion provided by this source
1
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
University of Kurdistan
Full name of responsible person
Dariush Sheikholeslami-Vatani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University of Kurdistan, Pasdaran Blvd, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617614741
Phone
+98 87 3366 4600
Email
d.vatani@uok.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Dariush Sheikholeslami-Vatani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University of Kurdistan, Pasdaran Blvd, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۷۶-۱۴۷۴۱
Phone
+98 87 3366 4600
Email
d.vatani@uok.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Dariush Sheikholeslami-Vatani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
66176-14741
Phone
+98 87 3366 4600
Email
d.vatani@uok.ac.ir
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
Some of the data such as information about the main outcome can be shared.
When the data will become available and for how long
Start of access period one month after publishing results
To whom data/document is available
The data will be available to researchers.
Under which criteria data/document could be used
In order to spread scientific information
From where data/document is obtainable
Electronic Email
What processes are involved for a request to access data/document