1. To assess the effect of liraglutide versus RF cavitation on waist circumference.
2. To assess their comparative effect on body mass index (BMI).
3. To assess their comparative effect on body weight.
4. To assess their comparative effect on lipid profile.
5. To assess their comparative effect on blood glucose profile.
6. To assess their comparative effect on the waist-to-hip ratio.
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 recieve 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
waist circumference and body mass index (BMI)
General information
Reason for update
Acronym
liraCav tial
IRCT registration information
IRCT registration number:IRCT20251003067486N1
Registration date:2025-11-01, 1404/08/10
Registration timing:prospective
Last update:2025-11-01, 1404/08/10
Update count:0
Registration date
2025-11-01, 1404/08/10
Registrant information
Name
Nazanin Eslamipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 1521
Email address
n.eslamipour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-06, 1404/08/15
Expected recruitment end date
2026-05-05, 1405/02/15
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:
obesity
Exclusion criteria:
Pregnancy
Drug abuse
Obesity due to specific endocrine disorders
Alcohol use
Specific diseasesuch as cancer
Age
From 35 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
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)
Double 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
Dr shariati st,gholhak junction amin pabarja street, ayeneh boulvard, corner of goleyakh street,headquarters building of islamic azad university, tehran faculty of medical science.
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
waist measurement
Timepoint
three months
Method of measurement
with aa measuring tape
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: radiofrequency cavitation
Category
Treatment - Devices
2
Description
Control group: liraglutide
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
کلینیک غدد بیمارستان فرهیختگان
Full name of responsible person
alireza aref zade
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
akram fath abadi
Street address
tehran,shariati street,gholhak crossroad,pabarja street,abne boulvard at the corner of goleyakh, islamic azad university, tehran medical science building