The main purpose was to compare the cost and effectiveness of combined exercises on insulin consumption and some related factors in type 2 diabetic patients.
Design
This study is a clinical trial.There is no possibility of blinding in this study.Initial measurements will be performed in the field of physical fitness, blood tests. Participants will practice according to the protocol. At the end of the quarterly period, final measurements will be performed similar to the initial measurements.
Settings and conduct
This study will be held in Zanjan. The metabolic training protocol will be performed by cardio exercises tailored to the athlete's condition for 12 weeks.The resistance training protocol will be the large muscles of the body.During the implementation of the training protocol, changes in insulin consumption will be in accordance with standard protocols and proportional to blood sugar levels.To assess the diet, a 24-hour diet recall questionnaire will be used before blood sampling. Important clinical considerations will be considered, including exercise intensity, food intake, and insulin.
Participants/Inclusion and exclusion criteria
Inclusion criteria are blood sugar levels have been controlled by insulin and participants who have the ability and interest to participate in training programs. Exclusion criteria are any illness or medical restriction for performing sports activities
Intervention groups
68 participants (40 to 60 years old) whose diabetes was controlled by insulin use will participate in this study.The intervention group will participate in a 12-week training protocol with an intensity of 50 to 75% HRmax and resistance training with 50 to 85% (1RM).The control group will have a normal life.
Main outcome variables
The main outcome is examine the changes in insulin consumption, treatment costs due to exercise in order to modify health insurance policies on the diabetes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180530039909N1
Registration date:2021-09-03, 1400/06/12
Registration timing:prospective
Last update:2021-09-03, 1400/06/12
Update count:0
Registration date
2021-09-03, 1400/06/12
Registrant information
Name
Mahmoud Hakami Zanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3341 1577
Email address
mahmoud1ir@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the cost and effectiveness analysis of combined exercises on insulin consumption and some related factors on type 2 diabetic patients
Public title
Comparison of the cost and effectiveness analysis of combined exercises on insulin consumption and some related factors on type 2 diabetic patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients whose blood sugar levels are controlled by insulin
Diabetic patients have the ability and interest to participate in exercise programs.
Exclusion criteria:
Patients have any illness or medical restrictions for participating in the exercise
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the coin toss method will be used. In this method, the lion side of the experimental group and the line side of the control group will be used to create a random sequence. Depending on the size of the sample, the coin will be flown and individuals will be divided into two randomly assigned groups.
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
Zanjan University of Medical Sciences (Research Ethics Committee)
Street address
Zanjan University of Medical Sciences,Professor Prof. Boulevard,Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2021-07-04, 1400/04/13
Ethics committee reference number
IR.ZUMS.REC.1400.135
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
ICD-10-E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
The main variables measured in this study are the amount of changes in the dose and cost of insulin consumption
Timepoint
Measurement sections will be pre-test and post-test
Method of measurement
The method of measuring the main outcome variable will be measuring the sugar profile and Insulin consumption as well as a researcher-made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will participate in a combined exercise program for 12 weeks and 3 sessions per week. This combination exercise program will include metabolic exercises with a gradual increase in intensity between 50 and 70% of the MaxHR. The resistance training section will also be between 50 and 85% of 1RM for large muscle groups with gradually increasing intensity.
Category
Lifestyle
2
Description
Control group: The control group will have a normal life.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Health Insurance Research Unit
Full name of responsible person
Fatemeh Mohammadi
Street address
Health Insurance Organization, Mehraneh Blvd, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
56182-45139
Phone
+98 24 3313 4101
Email
info.zn@ihio.gov.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Health Insurance Research Center
Full name of responsible person
Parvaneh Keyhani
Street address
Entrance A, No. 1, Corner of Derakhshan St, North Flamek St, Ivanak Blvd, Farahzadi Blvd, Sanat Square, Gharb Town, Tehran, Iran
City
Zanjan
Province
Zanjan
Postal code
146786343
Phone
+98 21 9688 1860
Email
nchir@ihio.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Health Insurance Research Center
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
Zanjan University of Medical Sciences
Full name of responsible person
Mahmoud Hakami
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Dpt physical education, Shahrak karmandan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
0098 24 330180
Email
mahmoud1ir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahmoud Hakami Zanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
No.4241, Mehr, Azadegan.
City
Zanjan
Province
Zanjan
Postal code
4513755391
Phone
+98 24 3341 1577
Fax
Email
mahmoud1ir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahmoud Hakami Zanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
NO. 4241, Mehr, Azadegan.
City
Zanjan
Province
Zanjan
Postal code
4513755391
Phone
+98 24 3341 1577
Fax
Email
mahmoud1ir@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
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
The sections that contribute to the production of science in the title of this study will be shared
When the data will become available and for how long
The data access period will start 6 months after the results are published
To whom data/document is available
The data of this study will be available to all researchers
Under which criteria data/document could be used
The data will only be usable for citation
From where data/document is obtainable
mahmoud1ir@yahoo.com
This email will be the communication channel for receiving documents
What processes are involved for a request to access data/document
When the request was received via email. That request will be considered. If it was in accordance with the conditions of this study. Submission data will be sent within one month