Ultrasound Lipolysis Versus Cryolipolysis On Lipid Profile Levels In Centrally Obese Middle Aged Men
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-60
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound lipolysis
DeviceUltrasound 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
DeviceThe 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
Other interventionA 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%).
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: ultrasound lipolysis groupExperimental treatment 2 interventions
Group B: cryolipolysis groupActive comparator 2 interventions
Group C: low caloric diet groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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%).
Time frame
at baseline and after 3 monthsSecondary outcomes
1
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
Time frame
at baseline and after 3 months2
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.
Time frame
at baseline and after 3 months3
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
Time frame
at baseline and after 3 months4
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.
Time frame
at baseline and after 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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