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This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryolipolysis and aerobic exercise group | Experimental | 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. |
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| aerobic exercise group | Active Comparator | The participants received aerobic exercises on treadmill only for 30 minutes/ 2sessions per week for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryolipolysis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum interleukin-6 | 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. | 12 weeks |
| C- Reactive Proteins | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | weight-height scale was used to calculate body weight (kilogram) for all participants before and after intervention. | 12 weeks |
| Body mass index | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samira Swdky, Professor | Al-Azhar University | Study Director |
| Abeer ElDeeb, Professor | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nada ElSayed Mohamed | Cairo | Egypt |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| aerobic exercise | Other | 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) |
|
| 12 weeks |
| waist circumference | 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). | 12 weeks |
| Hip circumference | Hip circumference was measured by the tape at the level of grater trochanter (centimeter). | 12 weeks |
| waist-hip ratio | waist-hip ratio was calculated by dividing waist circumference over hip circumference, before and after the study intervention. | 12 weeks |
| Muscle mass | 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. | 12 weeks |
| Body fat weight | 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. | 12 weeks |
| Body fat percentage | 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. | 12 weeks |
| Visceral fat | 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. | 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |