Obesity
Conditions
Brief summary
This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women.
Detailed 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.
Interventions
DEVICECryolipolysis
Vacuum controllable head with cold temperature range from -10 to 5°C technique was adjusted according to each patient tolerance, after careful patient sensation examination and vital signs evaluation before and after each session. Cryolipolysis sessions was applied at the hypogastrium area, 5 cm below the umbilicus, for 30 minutes with temperature degree of -5°C using an anti- freezing membrane to avoid cold burn. After starting the device on, the patient was instructed with safety measures to pull the key off if there was any intolerable abnormal sensation.
OTHERaerobic exercise
Participants received moderate intensity aerobic exercises 2 times/week for 12 weeks by using treadmill. Each session took about 30 minutes as the following: 5 minutes warming up exercises by walking on the treadmill by low speed, 20 minutes walking at moderate intensity (70% of the maximal heart rate) and 5 minutes are cooling down by walking on the treadmill with low speed as in warming up (2 sessions/week)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C- Reactive Proteins | 12 weeks | Serum C-reactive protein (CRP) levels were measured from venous blood samples using an immunoturbidimetric assay. CRP concentrations were expressed in milligrams per liter (mg/L). A CRP value below 5 mg/L is generally considered within the normal range. Higher levels indicate inflammatory diseases. |
| Serum interleukin-6 | 12 weeks | Serum interleukin-6 (IL-6) levels were measured from venous blood samples using an enzyme-linked immunosorbent assay (ELISA). IL-6 concentrations were expressed in picograms per milliliter (pg/mL). The normal serum IL-6 level in healthy adults is generally less than 7 pg/mL, higher level indicates inflammatory conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 12 weeks | weight-height scale was used to calculate body weight (kilogram) for all participants before and after intervention. |
| Body mass index | 12 weeks | weight-height scale was used to calculate body mass index for all participants before and after intervention, it was calculated by dividing weight in kilogram by height square meters. |
| waist circumference | 12 weeks | waist circumference was measured by the tape at the midpoint between the iliac crest and lowest rib margins at the end of normal expiration (centimeter). |
| Hip circumference | 12 weeks | Hip circumference was measured by the tape at the level of grater trochanter (centimeter). |
| waist-hip ratio | 12 weeks | waist-hip ratio was calculated by dividing waist circumference over hip circumference, before and after the study intervention. |
| Muscle mass | 12 weeks | A body composition scale (eufy Smart Scale P1 with Bluetooth and its mobile software) was used to assess muscle mass (%). The patient stood on the device platform wearing light clothing, maintaining full contact with the electrodes for 30 seconds until measurements were completed and recorded automatically. The measurement was performed three times, and the average value was calculated. |
| Body fat percentage | 12 weeks | A body composition scale (eufy Smart Scale P1 with Bluetooth and its mobile software) was used to assess Body fat percentage (%). The patient stood on the device platform wearing light clothing, maintaining full contact with the electrodes for 30 seconds until measurements were completed and recorded automatically. The measurement was performed three times, and the average value was calculated. |
| Body fat weight | 12 weeks | A body composition scale (eufy Smart Scale P1 with Bluetooth and its mobile software) was used to assess Body fat weight (KG). The patient stood on the device platform wearing light clothing, maintaining full contact with the electrodes for 30 seconds until measurements were completed and recorded automatically. The measurement was performed three times, and the average value was calculated. |
| Visceral fat | 12 weeks | A body composition scale (eufy Smart Scale P1 with Bluetooth and its mobile software) was used to assess Visceral fat (%). The patient stood on the device platform wearing light clothing, maintaining full contact with the electrodes for 30 seconds until measurements were completed and recorded automatically. The measurement was performed three times, and the average value was calculated. |
Countries
Egypt
Contacts
STUDY_DIRECTORSamira Swdky, Professor
Al-Azhar University
STUDY_CHAIRAbeer ElDeeb, Professor
Cairo University
Outcome results
None listed