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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lipid Profile; Central Obesity; Ultrasound Lipolysis; Cryolipolysis
• Intervention / Treatment: Device: Ultrasound lipolysis; Other: Low Caloric Diet; Device: Cryolipolysis

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 Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa awad Ali, physical therapist; Phone Number: 01050366830; Email: mustafaawad279@gmail.com

Study Locations

• Egypt
  • Giza, Egypt
    • out-patient clinic, faculty of physical therapy, Cairo university
    • Contact: Mustafa Awaf Ali, assistant lecturer; Phone Number: 01050366830; Email: mustafaawad279@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.; Other: 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%).
Active Comparator: 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	Other: 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%).; Device: 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.
Active Comparator: low caloric diet group; it involves 22 participants and will receive low caloric diet treatment for 3 months.	Other: 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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%).	at baseline and after 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	at baseline and after 3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): November 5, 2024
• Primary Completion (Estimated): March 5, 2025
• Study Completion (Estimated): April 5, 2025

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Abdominal
• Other Study ID Numbers: Mustafa-004363

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No