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NCT Number: NCT06658639

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.

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Key information

Conditions

Ultrasound Lipolysis Body Weight Central Obesity Cryolipolysis Lipid Profile Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Giza, Egypt

Location contact

Mustafa Awaf Ali, assistant lecturer

CONTACT

[email protected]

01050366830

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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%).

Primary outcomes

  1. assessment of change of lipid profile

    Time frame: at baseline and after 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%).

Secondary outcomes

  1. assessment of BMI using Body weight and height scale

    Time frame: at baseline and after 3 months

    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

  2. assessment of change of skin fold thickness using skin caliper

    Time frame: at baseline and after 3 months

    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.

  3. assessment of change of Waist Circumference using tape measurement

    Time frame: at baseline and after 3 months

    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

  4. assessment of change of Waist Hip Ratio

    Time frame: at baseline and after 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mustafa awad Ali, physical therapist

CONTACT

[email protected]

01050366830

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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