Effect of Cryolipolysis on Inflammatory Factors in Obese Postmenopausal Women
24 czerwca 2026 zaktualizowane przez: Nada Elsayed Mohamed, Cairo University
This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
46
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Cairo, Egipt
- Nada ElSayed Mohamed
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Cryolipolysis and aerobic exercise group
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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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.
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)
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Aktywny komparator: aerobic exercise group
The participants received aerobic exercises on treadmill only for 30 minutes/ 2sessions per week for 12 weeks.
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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)
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Serum interleukin-6
Ramy czasowe: 12 weeks
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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.
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12 weeks
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C- Reactive Proteins
Ramy czasowe: 12 weeks
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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.
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12 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Body weight
Ramy czasowe: 12 weeks
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weight-height scale was used to calculate body weight (kilogram) for all participants before and after intervention.
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12 weeks
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Body mass index
Ramy czasowe: 12 weeks
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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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12 weeks
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waist circumference
Ramy czasowe: 12 weeks
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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).
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12 weeks
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Hip circumference
Ramy czasowe: 12 weeks
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Hip circumference was measured by the tape at the level of grater trochanter (centimeter).
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12 weeks
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waist-hip ratio
Ramy czasowe: 12 weeks
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waist-hip ratio was calculated by dividing waist circumference over hip circumference, before and after the study intervention.
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12 weeks
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Muscle mass
Ramy czasowe: 12 weeks
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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.
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12 weeks
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Body fat weight
Ramy czasowe: 12 weeks
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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.
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12 weeks
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Body fat percentage
Ramy czasowe: 12 weeks
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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.
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12 weeks
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Visceral fat
Ramy czasowe: 12 weeks
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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.
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12 weeks
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Krzesło do nauki: Abeer ElDeeb, Professor, Cairo University
- Dyrektor Studium: Samira Swdky, Professor, Al-Azhar University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 stycznia 2025
Zakończenie podstawowe (Rzeczywisty)
15 lipca 2025
Ukończenie studiów (Rzeczywisty)
30 lipca 2025
Daty rejestracji na studia
Pierwszy przesłany
24 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
24 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
30 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
30 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 012/004731
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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