Evaluation of the effectiveness of microwave technology on reducing abdominal fat and plasma levels of Leptin and Adiponectin
Design
This is an interventional study. After obtaining informed consent from participants and determining the indications of the appropriateness of microwave, 30 healthy people aged 18 to 65 years with overweight and body mass index (BMI) of less than 30 kg/m2 are included in the study.
Settings and conduct
This study will be performed in an obesity treatment clinic. In the first session, demographic information and anthropometric parameters are measured. 5 cc of non-fasting venous blood sample is taken. Participants are given an isocaloric diet. Then treated with microwaves. This process is repeated in the second session of the intervention (20 days after the first session) and also 20 days after the second and third intervention. In order to control dietary intakes, food frequency questionnaire is completed. In order to control the energy consumption of individuals, the IPAQ body activity questionnaire verified for the Iranian population will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Filling in the moral consent or the absence of a legal prohibition to intervene, Age 65-18 years, Body mass index less than 30 kg/m2
Intervention groups
According to the standard treatment protocol, patients are treated with microwave technology (2.5 GHz radiofrequency) using Onda device (Onda, DEKA technology, Florence, Italy) for 3 sessions with an interval of 20 days.
Main outcome variables
Body mass index;
Percentage of body fat;
waist circumference:
Subcutaneous adipose tissue thickness;
Intra-abdominal adipose tissue volume;
Blood levels of adiponectin, leptin and lipoprotein lipase;
Prooxidane-Antioxidant Balance (PAB);
Daily calorie intake;
Daily physical activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181010041303N1
Registration date:2020-11-15, 1399/08/25
Registration timing:registered_while_recruiting
Last update:2020-11-15, 1399/08/25
Update count:0
Registration date
2020-11-15, 1399/08/25
Registrant information
Name
mahsa malekahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8823 1578
Email address
malekahmadim951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-27, 1399/08/06
Expected recruitment end date
2020-11-26, 1399/09/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of microwaves platform on reduction of abdominal subcutaneous fat and plasma leptin and adiponectin level.
Public title
Effect of microwaves platform on reduction of abdominal subcutaneous fat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy people aged 18 to 65 years
overweight with a body mass index (BMI) of less than 30 kg / m2
Intra-abdominal fat volume less than 12 kg
Absence of active cancer (chemotherapy / radiotherapy) in the last 6 months
No non-invasive lipolysis in the abdomen or other parts of the body in the last 3 months
completing a moral consent or no legal prohibition on intervention
Absence of abdominal surgery in the last 6 months
Absence of acute heart disease in the last 6 months
Absence of liver cirrhosis in the last 6 months
Exclusion criteria:
Pregnancy and lactation
Use of anticoagulants (other than aspirin)
Use of isotretinoin drugs
Secretion skin lesions and active eczema on the surface of the abdominal skin
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
School of Medicine, east door of the university campus, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
0071151303
Approval date
2020-10-26, 1399/08/05
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.444
Health conditions studied
1
Description of health condition studied
overweight
ICD-10 code
E66.3
ICD-10 code description
Overweight
Primary outcomes
1
Description
Body mass index: ratio of weight (kg) to height2 (m2)
Timepoint
At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start
Method of measurement
Using the formula weight (kg)/ height 2 (m2)
2
Description
Percentage of body fat
Timepoint
At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start
Method of measurement
with body analyzer
3
Description
waist circumference
Timepoint
At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start
Method of measurement
Using a tape measure
4
Description
The thickness of the subcutaneous fat tissue of the abdomen
Timepoint
At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start
Method of measurement
By ultrasound device
5
Description
Intra-abdominal adipose tissue volume
Timepoint
At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start
Method of measurement
By ultrasound device
6
Description
serum levels of adiponectin
Timepoint
At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start
Method of measurement
ELISA kit
7
Description
Serum levels of lipoprotein lipase
Timepoint
At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start
Method of measurement
ELISA kit
8
Description
Prooxidane-Antioxidant Balance (PAB)
Timepoint
At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start
Method of measurement
By calorimetric method
9
Description
Serum levels of leptin
Timepoint
At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start
Method of measurement
ELISA kit
Secondary outcomes
1
Description
daily calorie intake
Timepoint
baseline
Method of measurement
food frequency questionnaire
2
Description
daily physical activity
Timepoint
baseline
Method of measurement
IPAQ questionnaire
Intervention groups
1
Description
Intervention group:According to the standard treatment protocol, patients are treated with microwave technology (2.5 GHz radiofrequency) using Onda device (Onda, DEKA technology, Florence, Italy) for 3 sessions with an interval of 20 days. Participants are also given an isocaloric diet. This process is repeated in the second session of the treatment intervention (20 days after the first session) and also 20 days after the second and third intervention.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Behbood clinic
Full name of responsible person
Abdolreza Norouzy
Street address
Behbood Clinic, corner of 14th Alley, the beginning of North Mofteh, Shahid Beheshti Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15877844611
Phone
+98 21 8817 1901
Email
norouzya@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdolreza Norouzy
Street address
School of Medicine, east door of the university campus, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
0071151303
Phone
+98 51 3882 7034
Email
norouzya@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Artiman
Proportion provided by this source
100
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdolreza Norouzy
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, east door of the university campus, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
0071151303
Phone
+98 51 3882 7034
Email
norouzya@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdolreza
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, east door of the university campus, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
0071151303
Phone
+98 51 3882 7034
Email
norouzya@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdolreza Norouzy
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, east door of the university campus, Azadi Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
0071151303
Phone
+98 51 3882 7034
Email
norouzya@mums.ac.ir
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