Improved fatty liver index- induced high-intensity interval training associated with decrease liver enzyme plasma levels and metabolic parameters in type 2 diabetes
The aim of this study was to investigate the effect of High Intensity Interval Training (HIIT) on the improvement of fatty liver biomarkers associated with reduced liver enzymes and metabolic parameters in type 2 diabetes.
Design
The present study is a double-blind randomized clinical trial . 40 patients are divided into intervention and control groups. The intervention group uses HIIT exercise in addition to general therapies. Excel software rand function was used for randomization. Due to the lack of drug interventions, the term "phase" is not applicable to the present study.
Settings and conduct
Participants received their intervention in groups. The location of the project is Loghman Hakim Hospital. Blood samples are collected 24 hours before exercise and 48 hours after interventions. At the beginning of the research, a code will be assigned to each subject and in all subsequent steps, the code will be used instead of the names of the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 diabetic patients of Loghman Hakim Hospital age limit (45 to 60 years) Male weight. A1C more than 6%
Exclusion criteria: Neuromuscular diseases, Nephropathy, Hypertension, Myocardial infarction and Bypass surgery
Intervention groups
The control group of the subjects of this group will not have any regular sports activities and will receive only the usual hospital treatments.
The intervention group of subjects in this group will perform three sessions per week of HIIT training with 80% of maximum heart rate for 4 weeks.
Main outcome variables
Lipid profile, glycemic indexe, liver enzymes and renal function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200729048246N1
Registration date:2020-08-21, 1399/05/31
Registration timing:retrospective
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
hoseyn fatolahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7628 1010
Email address
hoseyn.fatolahi@pardisiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-01, 1398/02/11
Expected recruitment end date
2019-06-01, 1398/03/11
Actual recruitment start date
2019-06-02, 1398/03/12
Actual recruitment end date
2019-07-02, 1398/04/11
Trial completion date
2020-09-02, 1399/06/12
Scientific title
Improved fatty liver index- induced high-intensity interval training associated with decrease liver enzyme plasma levels and metabolic parameters in type 2 diabetes
Public title
Response of metabolic parameters to 4 weeks of High Intensity Interval Training (HIIT)
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients of Loghman Hakim Hospital
A1C more than 6%
Lack of Orthopedic diseases
Age limit (45 to 60 years)
male and female
lack of neuromuscular disease
lack of Nephropathy
lack of Hypertension
lack of Myocardial infarction
lack of Bypass surgery
Exclusion criteria:
Orthopedic diseases
neuromuscular disease
Nephropathy
Hypertension
Myocardial infarction
Bypass surgery
Age
From 45 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using a computer and simple randomization. The software randomly selects numbers between 1 and 0 and numbers less than 0.5 will be in the control group and numbers greater than 0.5 will be in the intervention group. Finally, 40 subjects will be divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects were coded instead of using their names. From an uninformed person Was asked to randomly distribute the codes. Study groups instead
The group name had a code. Laboratory of the names of groups and participants was informed and used codes. Codes were also used for statistical analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Loghman Hakim clinical research development center
Street address
Kargar South Kamali St. Loghman Hakim Medical and Educational Center Clinical Research Development Center
City
Tehran
Province
Tehran
Postal code
1333631151
Approval date
2019-09-01, 1398/06/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.187
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
ICD-10 code description
Type 2 diabetes
Primary outcomes
1
Description
liver enzyme plasma levels
Timepoint
24 hours before the intervention period and 48 hours after the intervention period
Method of measurement
ELISA
Secondary outcomes
1
Description
Fatty liver index
Timepoint
24 hours before the intervention period and 48 hours after the intervention period
Method of measurement
Fatty liver index (FLI) is a non-invasive method for assessing hepatic steatosis which calculated by following formula: FLI= (e 0.953 × loge (triglycerides) + 0.139 × BMI + 0.718 × loge (GGT) + 0.053 × waist circumference – 15.745)/ (1 + e 0.953 × loge (triglycerides) + 0.139 × BMI + 0.718 × loge (GGT) + 0.053 × waist circumference – 15.745) × 100. The FLI was calculated in each subjects.
2
Description
Lipid profile
Timepoint
24 hours before the intervention period and 48 hours after the intervention period
Method of measurement
ELISA
3
Description
HbA1c
Timepoint
24 hours before the intervention period and 48 hours after the intervention period
Method of measurement
ELISA
4
Description
Renal function, measurement of urea and creatinine
Timepoint
24 hours before the intervention period and 48 hours after the intervention period
Method of measurement
Quantified by photometry
Intervention groups
1
Description
All of the participants conducted supervised HIIT on cycling ergometer (894E Monark Ergomedic Peak Bike, Varberg, Sweden) three sessions per week for 4- weeks. Each session of HIIT consisted of 4-intervals (1 min) at 80% maximal heart rate (HRmax) separated by 4 min at 70% HRmax. Each training session was start by 5 min of warm-up, which including walking, running and stretching movements at 40% HRmax. The participants ended the session of exercise training with 5 min at 40% HRmax as cool-down. To ensure appropriate intensity, all patients wore a heart rate monitor (Polar Beat, Polar Electro) during each exercise session.
Category
Lifestyle
2
Description
Control group: The subjects in this group will not have any regular exercise and will only use the usual treatments for type 2 diabetes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Educational Medical Center
Full name of responsible person
ِDr Saeed Kalbasi
Street address
Kargar South Kamali St. Loghman Hakim Medical and Educational Center Clinical Research Development Center
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Fax
+98 21 5541 6130
Email
Lcrdc@sbmu.ac.ir
Web page address
http://www.sbmu.ac.ir/sitedirectory/loghmanHakim
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Saeed Kalbasi
Street address
Kargar South Kamali St. Loghman Hakim Medical and Educational Center Clinical Research Development Center