Skip to content

Ultrasound Lipolysis Versus Cryolipolysis On Lipid Profile Levels In Centrally Obese Middle Aged Men

Ultrasound Lipolysis Versus Cryolipolysis On Lipid Profile Levels In Centrally Obese Middle Aged Men

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06658639
Enrollment
66
Registered
2024-10-26
Start date
2024-11-05
Completion date
2025-04-05
Last updated
2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Lipolysis, Cryolipolysis, Lipid Profile, Central Obesity

Brief 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. 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

Interventions

DEVICEUltrasound 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.

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.

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%).

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
40 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Obese men with middle age range will be 40-60 years. 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

1. Chronic respiratory disorders and cardiovascular problems. 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.

Design outcomes

Primary

MeasureTime frameDescription
assessment of change of lipid profileat baseline and after 3 monthsA 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%).

Secondary

MeasureTime frameDescription
assessment of BMI using Body weight and height scaleat baseline and after 3 monthsFor 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
assessment of change of skin fold thickness using skin caliperat baseline and after 3 monthsA 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.
assessment of change of Waist Circumference using tape measurementat baseline and after 3 monthsA 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
assessment of change of Waist Hip Ratioat baseline and after 3 monthsUsing 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.

Countries

Egypt

Contacts

Primary ContactMustafa awad Ali, physical therapist
mustafaawad279@gmail.com01050366830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026