Ultrasound Lipolysis Versus Cryolipolysis On Lipid Profile Levels In Centrally Obese Middle Aged Men
NCT ID: NCT06658639
Last Updated: 2024-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2024-11-05
2025-04-05
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ultrasound lipolysis group
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
Ultrasound lipolysis
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.
Low Caloric Diet
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%).
cryolipolysis group
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
Cryolipolysis
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 Diet
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%).
low caloric diet group
it involves 22 participants and will receive low caloric diet treatment for 3 months.
Low Caloric Diet
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%).
Interventions
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Ultrasound lipolysis
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.
Cryolipolysis
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 Diet
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%).
Eligibility Criteria
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Inclusion Criteria
2. Obese men with central obesity.
3. Body mass index (BMI) greater than 30 Kg \\m2.
4. Waist circumference will be \>94 cm.
5. Waist to hip ratio more than 0.9
Exclusion Criteria
2. Diabetic patients.
3. Presence of skin diseases in abdominal regions that prevent the use of ultra sound or cryolipolysis therapy.
4. Men with kidney or liver diseases.
5. Tumor diseases
6. Lesions of higher center leading to obesity.
7. History of active or chronic infectious, autoimmune disease.
8. History of abdominal surgeries.
40 Years
60 Years
MALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mustafa awad ali awad
principal investigator
Locations
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out-patient clinic, faculty of physical therapy, Cairo university
Giza, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Mustafa-004363
Identifier Type: -
Identifier Source: org_study_id
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