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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство 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.
• Устройство 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.
• Другое 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%).

Первичные конечные точки

• assessment of change of lipid profile [Срок оценки: at baseline and after 3 months]

Вторичные конечные точки (4)

• assessment of BMI using Body weight and height scale [Срок оценки: at baseline and after 3 months]
• assessment of change of skin fold thickness using skin caliper [Срок оценки: at baseline and after 3 months]
• assessment of change of Waist Circumference using tape measurement [Срок оценки: at baseline and after 3 months]
• assessment of change of Waist Hip Ratio [Срок оценки: at baseline and after 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• out-patient clinic, faculty of physical therapy, Cairo university — Giza

Идентификаторы

NCT: NCT06658639 · Mustafa-004363

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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