Ultrasound LipolysisNCT06658639
Ultrasound Lipolysis Versus Cryolipolysis On Lipid Profile Levels In Centrally Obese Middle Aged Men
A study testing Ultrasound lipolysis, Cryolipolysis and Low Caloric Diet in people with Ultrasound Lipolysis and Cryolipolysis, run by Cairo University at 1 site in Egypt.
Trial summary
The study compares the effects of ultrasound lipolysis and cryo lipolysis on cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, body mass index, skin thickness, waist circumference, and waist hip ratio in centrally obese middle aged men. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Ultrasound Lipolysis, Cryolipolysis, Lipid Profile
- What is being tested?
- Ultrasound lipolysis, Cryolipolysis and Low Caloric Diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2024to 5 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Obese men with middle age range will be 40-60 years.
- Obese men with central obesity.
- Body mass index (BMI) greater than 30 Kg \m2.
- Waist circumference will be >94 cm.
- Waist to hip ratio more than 0.9
Who cannot join
- Chronic respiratory disorders and cardiovascular problems.
- Diabetic patients.
- Presence of skin diseases in abdominal regions that prevent the use of ultra sound or cryolipolysis therapy.
- Men with kidney or liver diseases.
- Tumor diseases
- Lesions of higher center leading to obesity.
- History of active or chronic infectious, autoimmune disease.
- History of abdominal surgeries.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, Cairo university
Giza
Mustafa Awaf Ali, assistant lecturer, 01050366830, mustafaawad279@gmail.com
About this study
The study compares the effects of ultrasound lipolysis and cryo lipolysis on cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, body mass index, skin thickness, waist circumference, and waist hip ratio in centrally obese middle aged men. It also investigates the impact of ultrasound lipolysis on skin thickness, waist circumference, and waist hip ratio.
Read the detailed description
Obesity has become a key risk factor for the development of cardiovascular diseases and dyslipidemia. Overweight and abdominal obesity has increased in men more than in women.
For young individuals, intra-abdominal fat is the important component of the body fat for six of the eight metabolic risk factors. Intra-abdominal fat might contribute to that most patients with acute myocardial infarction at a young age are men.
Abdominal lipolysis by ultra sonic is a safe and efficacious method and can effectively decrease waist circumference, waist hip ratio and blood cholesterol.
Adding cryolipolysis to a low-calorie diet is protocol from other methods to improve the body profile, in form of body mass index, waist-to-hip ratio, as well subcutaneous fat tissues thickness, but also leads to improvement in lipid profile and liver enzymes
- Conditions
- Ultrasound Lipolysis, Cryolipolysis, Lipid Profile, Central Obesity
- Being tested
- Ultrasound lipolysis, Cryolipolysis, Low Caloric Diet
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound lipolysisDevice
Ultrasound lipolysis uses a Luvitra device to emit low-frequency ultrasound pulsed waves. The abdominal area is divided into two sections and the patient is placed in a comfortable supine lying position. The cavitation head is applied slowly to each segment in small circular movements. The treatment lasts 30 minutes on each side, with each session lasting 60 minutes. The same abdominal area is treated every two weeks for three months. The procedure involves cleaning the skin with alcohol cotton.
CryolipolysisDevice
The study utilized Lipocool, a cryolipolysis apparatus from Korea, with a thermoelectric cooling element. Participants were treated with thermal coupling gel on their abdomen, and the tissue was drawn into the applicator with a moderate vacuum. The device was used for 40-50 minutes, with energy extraction controlled by sensors. The system stopped cold exposure and the clinician released the vacuum. Participants underwent cryolipolysis sessions every 2 weeks for 3 months.
Low Caloric DietOther
A low-calorie diet is a structured plan that restricts daily caloric intake, often used for weight loss. It involves consuming 1,200 to 1,500 calories daily, creating a calorie deficit. However, it requires discipline and safety. The diet is low in fat (20-25%), high in complex carbohydrates (60%), and sufficient in protein (25-50%).
| Study group | Role | What they receive |
|---|---|---|
| ultrasound lipolysis group | Experimental | it involves 22 participants and will receive ultrasound lipolysis on abdominal area and low caloric diet treatment. abdominal area was treated for 60-minute session every 2 weeks for 3 months Receives: Device: Ultrasound lipolysis; Other: Low Caloric Diet |
| cryolipolysis group | Active comparator | it involves 22 participants and will receive cryolipolysis on abdominal area and low caloric diet treatment. Each participant underwent a cryolipolysis session on the same abdominal area every 2 weeks for 3 months Receives: Device: Cryolipolysis; Other: Low Caloric Diet |
| low caloric diet group | Active comparator | it involves 22 participants and will receive low caloric diet treatment for 3 months. Receives: Other: Low Caloric Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of change of lipid profile
A low-calorie diet is a structured plan that restricts daily caloric intake, often used for weight loss. It involves consuming 1,200 to 1,500 calories daily, creating a calorie deficit. However, it requires discipline and safety. The diet is low in fat (20-25%), high in complex carbohydrates (60%), and sufficient in protein (25-50%).
Measured: at baseline and after 3 months
Secondary outcomes (4)
assessment of BMI using Body weight and height scale
For measuring weight in kg and height in cm to calculate the body mass index (BMI) by dividing weight in kg on Height in meter square
Measured: at baseline and after 3 months
assessment of change of skin fold thickness using skin caliper
A caliper is used to measure suprailiac skinfold thickness where subcutaneous fat is pulled away from the muscle with the caliper tongs situated at their ends. For men, the direction of fold pulling was vertical and is taken 2 cm to the side of the umbilicus.
Measured: at baseline and after 3 months
assessment of change of Waist Circumference using tape measurement
A tape, resistant to stretching will be used to measure the waist circumference at the midpoint in line between the lower border of the last felt rib and the iliac crest's highest point. All patients will standing in a comfortable position, with both feet in close proximity, both arms beside the body
Measured: at baseline and after 3 months
assessment of change of Waist Hip Ratio
Using a non-stretchable tape, the hips is measured at the widest part of the hip bones, and the waist is measured at the midpoint in line between the lower border of the last felt rib and the iliac crest's highest point then the WHR will calculated by dividing the waist measurement by the hip measurement.
Measured: at baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start5 Nov 2024 (estimated)
- Primary completion5 Mar 2025 (estimated)
- Study completion5 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound LipolysisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa awad ali awad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658639
- Sponsor's protocol ID
- Mustafa-004363
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Lipolysis Versus Cryolipolysis On Lipid Profile Levels In Centrally Obese Middle Aged Men
- ClinicalTrials.gov ID
- NCT06658639
- Acronym / sponsor ID
- Mustafa-004363
- Conditions
- Ultrasound Lipolysis, Cryolipolysis, Lipid Profile, Central Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Nov 2024 (estimated)
- Primary completion
- 5 Mar 2025 (estimated)
- Study completion
- 5 Apr 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares the effects of ultrasound lipolysis and cryo lipolysis on cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, body mass index, skin thickness, waist circumference, and waist hip ratio in centrally obese middle aged men. It also investigates the impact of ultrasound lipolysis on skin thickness, waist circumference, and waist hip ratio.
Detailed description
Obesity has become a key risk factor for the development of cardiovascular diseases and dyslipidemia. Overweight and abdominal obesity has increased in men more than in women.
For young individuals, intra-abdominal fat is the important component of the body fat for six of the eight metabolic risk factors. Intra-abdominal fat might contribute to that most patients with acute myocardial infarction at a young age are men.
Abdominal lipolysis by ultra sonic is a safe and efficacious method and can effectively decrease waist circumference, waist hip ratio and blood cholesterol.
Adding cryolipolysis to a low-calorie diet is protocol from other methods to improve the body profile, in form of body mass index, waist-to-hip ratio, as well subcutaneous fat tissues thickness, but also leads to improvement in lipid profile and liver enzymes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ultrasound lipolysis group | Experimental | Device: Ultrasound lipolysis, Other: Low Caloric Dietit involves 22 participants and will receive ultrasound lipolysis on abdominal area and low caloric diet treatment. abdominal area was treated for 60-minute session every 2 weeks for 3 months |
| cryolipolysis group | Active comparator | Device: Cryolipolysis, Other: Low Caloric Dietit involves 22 participants and will receive cryolipolysis on abdominal area and low caloric diet treatment. Each participant underwent a cryolipolysis session on the same abdominal area every 2 weeks for 3 months |
| low caloric diet group | Active comparator | Other: Low Caloric Dietit involves 22 participants and will receive low caloric diet treatment for 3 months. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Obese men with middle age range will be 40-60 years.
- Obese men with central obesity.
- Body mass index (BMI) greater than 30 Kg \m2.
- Waist circumference will be >94 cm.
- Waist to hip ratio more than 0.9
Key exclusion criteria (8 listed)
- Chronic respiratory disorders and cardiovascular problems.
- Diabetic patients.
- Presence of skin diseases in abdominal regions that prevent the use of ultra sound or cryolipolysis therapy.
- Men with kidney or liver diseases.
- Tumor diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound lipolysisUltrasound lipolysis uses a Luvitra device to emit low-frequency ultrasound pulsed waves. The abdominal area is divided into two sections and the patient is placed in a comfortable supine lying position. The cavitation head is applied slowly to each segment in small circular movements. The treatment lasts 30 minutes on each side, with each session lasting 60 minutes. The same abdominal area is treated every two weeks for three months. The procedure involves cleaning the skin with alcohol cotton. | Device | ultrasound lipolysis group |
| CryolipolysisThe study utilized Lipocool, a cryolipolysis apparatus from Korea, with a thermoelectric cooling element. Participants were treated with thermal coupling gel on their abdomen, and the tissue was drawn into the applicator with a moderate vacuum. The device was used for 40-50 minutes, with energy extraction controlled by sensors. The system stopped cold exposure and the clinician released the vacuum. Participants underwent cryolipolysis sessions every 2 weeks for 3 months. | Device | cryolipolysis group |
| Low Caloric DietA low-calorie diet is a structured plan that restricts daily caloric intake, often used for weight loss. It involves consuming 1,200 to 1,500 calories daily, creating a calorie deficit. However, it requires discipline and safety. The diet is low in fat (20-25%), high in complex carbohydrates (60%), and sufficient in protein (25-50%). | Other | cryolipolysis group, low caloric diet group, ultrasound lipolysis group |
Primary outcome
assessment of change of lipid profile
Time frame: at baseline and after 3 months
A low-calorie diet is a structured plan that restricts daily caloric intake, often used for weight loss. It involves consuming 1,200 to 1,500 calories daily, creating a calorie deficit. However, it requires discipline and safety. The diet is low in fat (20-25%), high in complex carbohydrates (60%), and sufficient in protein (25-50%).
4 secondary outcomes
assessment of BMI using Body weight and height scale
Time frame: at baseline and after 3 months
assessment of change of skin fold thickness using skin caliper
Time frame: at baseline and after 3 months
assessment of change of Waist Circumference using tape measurement
Time frame: at baseline and after 3 months
assessment of change of Waist Hip Ratio
Time frame: at baseline and after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound lipolysis, Cryolipolysis and Low Caloric Diet in people with Ultrasound Lipolysis and Cryolipolysis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa awad Ali, physical therapist (01050366830, mustafaawad279@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of change of lipid profile (time frame: at baseline and after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.