To assess the effect of liraglutide versus RF cavitation on waist circumference and on body mass index (BMI)
Design
This study is a double-blind randomized clinical trial with a before-and-after design. sixth four obese participants with abdominal obesity will be randomly assigned into two groups of 32 each using simple randomization in Microsoft Excel. one group will receive Liraglutide injections(0.6-2.4 mg/day for six months) and the other will undergo radiofrequency cavitation therapy (weekly sessions for eight weeks). the researcher and data analyst will remain blinded to group allocation. Changes in body weight, BMI, and waist circumference will be evaluated before and after the interventions
Settings and conduct
Patients visiting the teaching clinics and affiliated health centers of the Islamic Azad university of medical sciences.
Control group: participants will receive Liraglutide injections (0.6-2.4 mg/day for six months). Intervention group: participants will undergo radiofrequency cavitation therapy weekly for eight weeks.
Main outcome variables
Abdominal circumference and body mass index (BMI)
General information
Reason for update
Acronym
liraCav tial
IRCT registration information
IRCT registration number:IRCT20150706023084N30
Registration date:2026-05-19, 1405/02/29
Registration timing:registered_while_recruiting
Last update:2026-05-19, 1405/02/29
Update count:0
Registration date
2026-05-19, 1405/02/29
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-06, 1404/08/15
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized Clinical Trial Comparing the Efficacy of Liraglutide and Radiofrequency Cavitation in the Management of Abdominal Obesity.
Public title
Comparison of the effects of liraglutide and radio frequency cavitaion on abdominal obesityof the effects of liraglutide and radio frequency cavitaion on abdominal obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All individuals without specific medical conditions, aged betweem 35 and 70 years
Obese and have a body mass index(BMI) higher than 27
Exclusion criteria:
Pregnancy
Drug abuse
Obesity due to specific endocrine disorders
Alcohol use
Specific diseases such as cancer
Age
From 35 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Using Microsoft Excel software, random allocation of participants into study groups was performed. for this purpose, the random number generation function in Microsoft excel was used to assign a random decimal number between 0 and 1 to each participant. these random numbers were then sorted in ascending order, and based on their order, participants were allocated to the intervention and control groups.this randomization method was applied to minimize selection bias and to ensure homogeneity of baseline characteristics between the study groups
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the difference in the type of interventions (subcutaneous liraglutide injection versus radiofrequency cavitation therapy), complete blinding of participants and treating staff is not feasible. Therefore, the outcome assessor and data analyst will be blinded to the group allocation. The outcome evaluator (measuring weight, BMI, and waist circumference) and the statistical analyst will remain unaware of patient group assignments throughout the study. Accordingly, the trial is considered double-blind (evaluator- and analyst-blinded).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical Sciences
Street address
Tehran faculty of medical sciences, Headquarters building of Islamic Azad university, Gholhak junction Amin Pabarja Street. Dr shariati st.
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2025-10-22, 1404/07/30
Ethics committee reference number
IR.IAU.PS.REC.1404.452
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Abdominal measurement
Timepoint
Three months
Method of measurement
By measuring tape
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group consisted of 32 participants who underwent radiofrequency cavitation therapy over a period of 3 months. The treatment was performed at the Obesity and Physiotherapy Clinic of the Islamic Azad University of Medical Sciences and consisted of one 30-minute session per week applied to the abdominal region for the reduction of abdominal fat and central obesity.Radiofrequency cavitation is a noninvasive body contouring method that utilizes ultrasound waves and radiofrequency energy to reduce localized adipose tissue and improve skin tightness. At the end of the study, the investigated parameters measured at baseline and at the completion of the treatment period were compared
Category
Treatment - Devices
2
Description
Control group: liraglutide The control group consisted of 32 participants who received daily subcutaneous injections of liraglutide for a period of 3 months. The dosing regimen was administered as follows: 0.6 mg daily during the first week, 1.2 mg daily during the second week, 1.8 mg daily during the third week, 2.4 mg daily during the fourth week, and 3 mg daily from the fifth week until the end of the study, administered via subcutaneous injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
endocrinology clinic of farhikhtegan hospital
Full name of responsible person
Alireza Arefzade
Street address
“Tehran, end of Sattari Street North, University Square, opposite the Central Office of Islamic Azad University. farhikhtegan hospital
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4486 7262
Email
Alireza.arefzadeh@iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Farshad Hashemian
Street address
Islamic Azad university of Medical Sciences, Khaghani St., Gholhak crossroad, Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
+98 21 2260 0714
Email
info@iau.ac.ir
Web page address
https://tms.iau.ir/fa
Grant name
vice chancellor for research of Azad university of medical science
Grant code / Reference number
معاونت پژوهشی دانشگاه علوم پزشکی آزاد تهران واحد علوم دارویی
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
ََAlireza Arefzade
Position
Assistant Prof of Endocrinology & Metabolism
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Farhikhtegan hospital, opposite the Central Office of Islamic Azad University, end of North Sattari Street
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4486 7262
Email
Alireza.arefzadeh@iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Arefzade
Position
Assistant Prof of Endocrinology & Metabolism
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Farhikhtegan hospital, opposite the Central Office of Islamic Azad University, end of North Sattari Street
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4486 7262
Email
Alireza.arefzadeh@iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
َAssistant Professor of pharmacotherapy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Farhikhtegan hospital, opposite the Central Office of Islamic Azad University, end of North Sattari Street
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2264 0056
Fax
+98 21 2260 0714
Email
shiehmorteza@iaups.ac.ir
Web page address
http://iaups.iautmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD