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

NCT06658639 | Not Yet Recruiting

• 1 other identifier: Mustafa-004363
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Lipolysis; Cryolipolysis; Lipid Profile; Central Obesity

Outcome Measures

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%).

  at baseline and after 3 months

Secondary Outcomes (4)

• assessment of BMI using Body weight and height scale

  at baseline and after 3 months

• assessment of change of skin fold thickness using skin caliper

  at baseline and after 3 months

• assessment of change of Waist Circumference using tape measurement

  at baseline and after 3 months

• assessment of change of Waist Hip Ratio

  at baseline and after 3 months

Study Arms (3)

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

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

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.

Other: Low Caloric Diet

Interventions

Ultrasound lipolysis DEVICE

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.

ultrasound lipolysis group

Cryolipolysis DEVICE

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.

cryolipolysis group

Low Caloric Diet OTHER

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; low caloric diet group; ultrasound lipolysis group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

out-patient clinic, faculty of physical therapy, Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Mustafa awad Ali, physical therapist

CONTACT

01050366830; mustafaawad279@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: November 5, 2024
• Primary Completion: March 5, 2025
• Study Completion: April 5, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

EG (1)