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

Cairo University (CU)

Status: Not yet enrolling

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

Treatments: Device: Cryolipolysis; Other: Low Caloric Diet; Device: Ultrasound lipolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT06658639

Mustafa-004363

Details and patient eligibility

About

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.

Full 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

Enrollment: 66 estimated patients

Sex: Male

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 3 patient groups

ultrasound lipolysis group

Experimental group

Description:

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

Treatment:

Device: Ultrasound lipolysis

Other: Low Caloric Diet

cryolipolysis group

Active Comparator group

Description:

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

Treatment:

Device: Cryolipolysis

Other: Low Caloric Diet

low caloric diet group

Active Comparator group

Description:

it involves 22 participants and will receive low caloric diet treatment for 3 months.

Treatment:

Other: Low Caloric Diet