Clinical trial NCT06658639: Ultrasound Lipolysis Versus Cryolipolysis On Lipid Profile Levels In Centrally Obese Middle Aged Men
Official title: Ultrasound Lipolysis Versus Cryolipolysis On Lipid Profile Levels In Centrally Obese Middle Aged Men
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ultrasound Lipolysis
Cryolipolysis
Lipid Profile
Central Obesity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 66
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: assessment of change of lipid profile
timeFrame: at baseline and after 3 months
Secondary outcomes:
measure: assessment of BMI using Body weight and height scale
timeFrame: at baseline and after 3 months
measure: assessment of change of skin fold thickness using skin caliper
timeFrame: at baseline and after 3 months
measure: assessment of change of Waist Circumference using tape measurement
timeFrame: at baseline and after 3 months
measure: assessment of change of Waist Hip Ratio
timeFrame: at baseline and after 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: out-patient clinic, faculty of physical therapy, Cairo university
Study officials:
References: