Effect of Cryolipolysis on Inflammatory Factors in Obese Postmenopausal Women
24. juni 2026 oppdatert av: Nada Elsayed Mohamed, Cairo University
This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
46
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Cairo, Egypt
- Nada ElSayed Mohamed
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Aktiv 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Serum interleukin-6
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Body weight
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Abeer ElDeeb, Professor, Cairo University
- Studieleder: Samira Swdky, Professor, Al-Azhar University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2025
Primær fullføring (Faktiske)
15. juli 2025
Studiet fullført (Faktiske)
30. juli 2025
Datoer for studieregistrering
Først innsendt
24. juni 2026
Først innsendt som oppfylte QC-kriteriene
24. juni 2026
Først lagt ut (Faktiske)
30. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 012/004731
Legemiddel- og utstyrsinformasjon, studiedokumenter
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