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

Not Applicable

Not yet recruiting

• Conditions: Ultrasound Lipolysis; Cryolipolysis; Lipid Profile; Central Obesity

• Registration Number: NCT06658639
• Lead Sponsor: Cairo University

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.

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Study Start: 2024-11-05
• Primary Completion: 2025-03-05
• Study Completion: 2025-04-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
assessment of change of lipid profile	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 Outcome Measures

Name	Time	Method
assessment of change of skin fold thickness using skin caliper	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.
assessment of change of Waist Circumference using tape measurement	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
assessment of change of Waist Hip Ratio	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.
assessment of BMI using Body weight and height scale	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

Trial Locations

Locations (1)

out-patient clinic, faculty of physical therapy, Cairo university; 🇪🇬 Giza, Egypt