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Comparison the Effect of Interval, Continuous and combined Aerobic Exercise on Liver Enzymes, IGF-1 and Insulin Hormone and Metabolic Syndrome in Overweight Type 2 Diabetic Patients with Nonalcoholic Fatty Liver

Protocol summary

Study aim
The aim of current study was to investigate and compare the effects of interval, continuous and combined aerobic exercise training on liver enzymes in type 2 diabetic patients with non-alcoholic fatty liver disease.
Design
A clinical trial with a control group, available as a sample and then randomized grouping
Settings and conduct
The research method was quasi-experimental with four control groups, interval aerobic training group, continuous aerobic training group and combined group (combination of interval and continuous aerobic training) with pretest and post test. Subjects were 48 type 2 diabetic women with fatty liver who had filed a case in the office of Dr. Fatemeh Razvan Madani. After reviewing the patients' files, about 60 eligible subjects were selected and after contacting patients, 48 of them were invited to start the study.
Participants/Inclusion and exclusion criteria
Entry criteria: All subjects were overweight according to BMI. The subjects were 40-55 years old. They were non-insulin dependent and used oral medications. The maximum glycosylated hemoglobin in these patients was 11. Exclusion criteria: Retinopathy, severe nephropathy, and neuropathy, a history of cardiovascular disease, neuromuscular and severe musculoskeletal problems that limit physical activity.
Intervention groups
Interval aerobic exercise group, with intensity of 75 to 80 percent of maximum heart rate Continuous aerobic exercise group, with intensity of 60 to 75 percent of maximal heart rate Combined aerobic training group, one interval session and one continuous session Control group, without regular exercise
Main outcome variables
Alanine amino transferase, aspartate amino transferase, alkaline phosphatase, glycosylated hemoglobin, fasting blood glucose, cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, waist circumference, blood pressure, IGF-1 hormone

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110527006611N3
Registration date: 2019-11-12, 1398/08/21
Registration timing: retrospective

Last update: 2019-11-12, 1398/08/21
Update count: 0
Registration date
2019-11-12, 1398/08/21
Registrant information
Name
Zahra Bayat
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 83 3822 9422
Email address
zahra_bayat2008@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2019-01-21, 1397/11/01
Trial completion date
2019-01-30, 1397/11/10
Scientific title
Comparison the Effect of Interval, Continuous and combined Aerobic Exercise on Liver Enzymes, IGF-1 and Insulin Hormone and Metabolic Syndrome in Overweight Type 2 Diabetic Patients with Nonalcoholic Fatty Liver
Public title
Comparison the Effect of Interval, Continuous and combined Aerobic Exercise on Liver Enzymes and Metabolic Syndrome in Overweight Type 2 Diabetic Patients with Nonalcoholic Fatty Liver
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects are type 2 diabetic women with non-alcoholic fatty liver. They are non-insulin-dependent They use oral medications for treatment (glibenclamide and metformin and sulfonylurease). The maximum blood glycosylated hemoglobin is 11%. The minimum history of diabetes is 1 year and the maximum history of diabetes is 15 years
Exclusion criteria:
Patients have retinopathy, nephropathy and severe neuropathy. Have a history of cardiovascular disease and musculoskeletal disorders Severe musculoskeletal problems that restrict physical activity
Age
From 40 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were classified according to fatty liver grade and then randomly divided into 4 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
Ethics Committee of Sport Sciences Research Institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street,
City
tehran
Province
Tehran
Postal code
1587958711
Approval date
2018-10-08, 1397/07/16
Ethics committee reference number
IR.SSRI.REC.1397.332

Health conditions studied

1

Description of health condition studied
Type 2 diabetes- Non-alcoholic fatty liver disease
ICD-10 code
E11-K76.0
ICD-10 code description
K76.0: Nonalcoholic fatty liver disease [NAFLD]-E11: Type 2 diabetes mellitus

Primary outcomes

1

Description
Alanine Aminotransferase enzyme
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Blood test with BioSystems kit

2

Description
Aspartate Aminotransferase enzyme
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Blood test with BioSystems kit

3

Description
Alkaline phosphatase enzyme
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Blood test with BioSystems kit

4

Description
Glycosylated hemoglobin
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Blood test with Pishtaz Teb kit

5

Description
HDL Cholesterol
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Blood test with BioSystems kit

6

Description
LDL Cholesterol
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Blood test with BioSystems kit

7

Description
Cholesterol
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Blood test with BioSystems kit

8

Description
triglyceride
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Blood test with BioSystems kit

9

Description
Waist circumference
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Standard tape meter

10

Description
Blood Pressure
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
brachial digital blood pressure monitor

11

Description
Fasting blood glucose
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Blood test with BioSystems kit

12

Description
IGF-1 Hormone
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Blood test with DiaSorin kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: interval aerobic exercise - The interval aerobic exercise group performed exercise on a stationary bike for two months, three days a week, with an intensity of 75 to 80 percent of maximum heart rate.
Category
Lifestyle

2

Description
Intervention group: Continuous aerobic exercise - The Continuous aerobic exercise group performed exercise on a stationary bike for two months, three days a week, with an intensity of 60 to 75 percent of maximum heart rate.
Category
Lifestyle

3

Description
Intervention group: Combined aerobic exercise - The combined aerobic exercise group performed exercise on a stationary bike for two months, three days a week, and in between sessions (continuous aerobic exercise and periodic aerobic exercise).
Category
Lifestyle

4

Description
Control group: No regular exercise
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Fatemeh Rezvan Madani office
Full name of responsible person
Fatemeh Rezvan Madani
Street address
the office of Dr. Rezvan Madani, Ground Floor, Negin Golestan Apartment, Chahardah Metri-ye-Shariat Street, Emami Blvd
City
kermanshah
Province
Kermanshah
Postal code
6714754418
Phone
+98 83 3844 2408
Email
rezvanimadani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
fatemeh rezvan madani
Street address
The Office of Dr. Rezvan Madani, Ground Floor, Negin Golestan Apartment, Chahardah Metri-ye- Shariat Street, Emami Blvd
City
kermanshah
Province
Kermanshah
Postal code
6714754418
Phone
+98 83 3844 2408
Email
rezvanimadani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Tehran
Proportion provided by this source
1
Public or private sector
Private
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 Tehran
Full name of responsible person
Zahra Bayat
Position
PhD Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Biochemistry and Metabolism
Street address
Kish International Campus, University of Tehran, Niyayesh St., Mirmohanna Blvd., Kish Island, Iran.
City
kish
Province
Hormozgan
Postal code
79416-55665
Phone
00987644433661-2
Email
z.bayat@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Reza Nuri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exersice Phisiology
Street address
Kish International Campus, University of Tehran, Niyayesh St., Mirmohanna Blvd., Kish Island, Iran
City
kish
Province
Hormozgan
Postal code
79416-55665
Phone
00987644433661-2
Email
nuri_r7@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Zahra Bayat
Position
PhD Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Biochemistry and Metabolism
Street address
Kish International Campus, University of Tehran, Niyayesh St., Mirmohanna Blvd., Kish Island, Iran.
City
kish island
Province
Hormozgan
Postal code
79416-55665
Phone
00987644433661-2
Email
z.bayat@ut.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The informed consent form will be available to others without mentioning the names of the participants. Details of the study process are also provided in detail in the file format.
When the data will become available and for how long
Start of the 8 month period after the research
To whom data/document is available
For university students and students in research related fields
Under which criteria data/document could be used
There are no specific conditions to provide such information.
From where data/document is obtainable
Zahra Bayat
What processes are involved for a request to access data/document
Send message to the person responsible for providing the data
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