The effect of 12 weeks of single and combined aerobic exercise and ketogenic diet control on improving RBP4, FABP5, SFRP5 levels and metabolic risk indices in middle-aged men with metabolic syndrome
the effect of 12 weeks of aerobic exercise with ketogenic diet on plasma levels of retinol-binding protein 4 (RBP4), fatty acid-binding protein 5 (FABP5), and secretory adipocaine associated with Friesland 5 protein (SFRP5) resistance, Insulin and metabolic risk indicators in middle-aged men with metabolic syndrome.
Design
A randomized controlled clinical trial with parallel groups, single-blind, randomized to 60 subjects, we use the restricted randomization method randomization of block type.
Settings and conduct
The study will be conducted at the Shahid Madani University of Azerbaijan. Laboratory tests before and after 12 weeks of exercise and dietary control will be performed in a single-blind manner.
Participants/Inclusion and exclusion criteria
Being in the middle age range of 60-40 years, Middle-aged men with type 2 diabetes mellitus (T2DM) , Diagnosis of hypertensive status , body mass index with a score of more than 30and waist circumference with a score of more than 102 cm, Having dyslipidemia
Intervention groups
Aerobic exercise group for 12 weeks / three sessions per week, ketogenic diet control for 12 weeks, combination of aerobic exercise and ketogenic diet control for 12 weeks and control group without exercise and ketogenic diet control
Main outcome variables
Measurement of RBP4, FABP5, SFRP5 levels and metabolic risk indices
General information
Reason for update
Acronym
MetS
IRCT registration information
IRCT registration number:IRCT20180724040579N3
Registration date:2021-06-09, 1400/03/19
Registration timing:prospective
Last update:2021-06-09, 1400/03/19
Update count:0
Registration date
2021-06-09, 1400/03/19
Registrant information
Name
Asgar Iranpour
Name of organization / entity
University of Mohaghegh Ardebili
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 7240
Email address
iranpoursport@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 12 weeks of single and combined aerobic exercise and ketogenic diet control on improving RBP4, FABP5, SFRP5 levels and metabolic risk indices in middle-aged men with metabolic syndrome
Public title
effect of aerobic training with ketogenic diet on insulin resistance and metabolic risk indices in middle-aged men with metabolic syndrome
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the middle age range of 60-40 years
Middle-aged men who have been diagnosed with type 2 diabetes mellitus (T2DM) for the past 24 months, according to criteria published in 1999 by the World Health Organization (WHO) in the range of 7 mmol / L or 126 Mg / dL and above)
Middle-aged men with type 2 diabetes who use oral hypoglycemic drugs without the need for insulin for survival
Diagnosis of hypertensive status (blood pressure levels equal to or greater than 140/90 mm Hg)
Middle-aged men with general obesity (body mass index with a score of more than 30) and central (waist circumference with a score of more than 102 cm)
Having dyslipidemia
Exclusion criteria:
Cardiovascular diseases
Thyroid disease
Liver and kidney diseases
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the restricted randomization method
randomization of block type. In this four-group experiment, We will have consisted of 12 blocks (including 3 participants in the aerobic exercise intervention group, 3 participants in the ketogenic diet control intervention group, 3 participants in the combined aerobic exercise intervention and ketogenic diet control intervention group and 3 participants in the control group).
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
Tabriz University of Medical Sciences
Street address
Central Building of University of Medical Sciences,Golgasht St, Azadi St, Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2020-12-14, 1399/09/24
Ethics committee reference number
IR.TBZMED.REC.1399.880
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary outcomes
1
Description
Changes in RBP4, FABP5, SFRP5 levels and metabolic risk indices
Timepoint
Before and after 12 weeks of exercise and diet control
Method of measurement
Using laboratory kits
Secondary outcomes
empty
Intervention groups
1
Description
Control group: without performing aerobic exercise and ketogenic diet control for 12 weeks
Category
N/A
2
Description
Intervention group: Aerobic exercise for 12 weeks / 3 sessions per week / 40-40 minutes per session
Category
Diagnosis
3
Description
Intervention group: Ketogenic diet control for 12 weeks
Category
Diagnosis
4
Description
Intervention group: Combining aerobic exercise for 12 weeks / 3 sessions per week / 40-60 minutes per session and ketogenic diet control for 12 weeks
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Azarbaijan Shahid Madani University
Full name of responsible person
Bahloul Ghorbanian
Street address
Shahid Madani University of Azerbaijan, 35 km Tabriz-Maragheh Road, Tabriz, EastAzarbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5375171379
Phone
+98 41 3432 7500
Email
b.gorbanian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azarbaijan Shahid Madani University
Full name of responsible person
Hossien Abdolmohammadzadeh
Street address
west side of office building, Shahid Madani University of Azerbaijan,35 km of Tabriz-Maragheh road
City
Tabriz
Province
East Azarbaijan
Postal code
5375171379
Phone
+98 41 2432 7526
Email
president@azaruniv.edu
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azarbaijan Shahid Madani University
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
Azarbaijan Shahid Madani University
Full name of responsible person
Bahloul Ghorbanian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Shahid Madani University of Azerbaijan, 35 km Tabriz-Maragheh Road, Tabriz, EastAzarbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5375171379
Phone
+98 41 3432 7500
Email
b.gorbanian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Azarbaijan Shahid Madani University
Full name of responsible person
Bahloul Ghorbanian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Shahid Madani University of Azerbaijan, 35 km Tabriz-Maragheh Road, Tabriz, East Azarbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5375171379
Phone
+98 41 3432 7500
Email
b.gorbanian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Asgar Iranpour
Position
P.H.D
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Mohaghegh Ardabili University, Daneshgah St, Ardabil city
City
Ardabil
Province
Ardabil
Postal code
5653171178
Phone
+98 45 3359 8237
Email
Iranpoursport@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available