Effect of Cryolipolysis on Inflammatory Factors in Obese Postmenopausal Women

Cairo University (CU)

Status: Completed

Conditions: Obesity

Treatments: Other: aerobic exercise; Device: Cryolipolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07676279

012/004731

Details and patient eligibility

About

This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women.

Full description

The onset of menopause is associated with a low systemic inflammatory status, an inflammation manifested by increased serum levels of the key proinflammatory cytokines, interleukin (IL)-1, IL-6 or tumor necrosis factor α (TNF-α).

Little information is available on menopause-related differences in inflammatory markers. Few studies have compared CRP levels and leptin in women as a function of menopausal status, finding no differences between premenopausal and postmenopausal women. The relationship between hormonal declines associated with menopause and increased serum levels of proinflammatory cytokines is not yet fully understood.

Cryolipolysis selectively destructs the fat cells, by decreasing the subcutaneous fat temperature through controlled cooling without causing any damage to the surrounding tissues Cryolipolysis induces an inflammation and fat cell fibrosis, which causes the death of adipocytes (apoptosis). Macrophages subsequently engulf and digest the dyed adipocytes and, thereby, gradually decreases the fat layer thickness, which may affect the inflammatory body reaction and factors. However, the systemic effect of Cryolipolysis alone was not approved.

Enrollment: 46 patients

Sex: Female

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All participants were postmenopausal women.
• Their ages were ranged from 50 to 60 years old.
• Body mass index was ranged from 30-40 kg/m2.
• Waist to hip Ratio was between 0.8-1.0.

Exclusion criteria

• Systematic disease (uncontrolled hypertension, diabetes mellitus).
• Thyroid, liver and kidney dysfunctions.
• Psychiatric disorders.
• Women received any hormonal therapy or received corticosteroids in the last six months prior to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Cryolipolysis and aerobic exercise group

Experimental group

Description:

The participants received cryolipolysis sessions on abdominal region (30 minutes/2 sessions per week for 12 weeks) in addition to moderate intensity Aerobic exercises on treadmill for 30 minutes/ 2sessions per week for 12 weeks.

Treatment:

Other: aerobic exercise

Device: Cryolipolysis

aerobic exercise group

Active Comparator group

Description:

The participants received aerobic exercises on treadmill only for 30 minutes/ 2sessions per week for 12 weeks.

Treatment:

Other: aerobic exercise