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Effect of Cryolipolysis on Inflammatory Factors in Obese Postmenopausal Women

24 de junio de 2026 actualizado por: Nada Elsayed Mohamed, Cairo University
This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

46

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Egipto
      • Cairo, Egipto
        • Nada ElSayed Mohamed

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Dispositivo: Cryolipolysis
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.
Otro: aerobic 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)
Comparador activo: aerobic exercise group
The participants received aerobic exercises on treadmill only for 30 minutes/ 2sessions per week for 12 weeks.
Otro: aerobic 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)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Serum interleukin-6
Periodo de tiempo: 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.
12 weeks
C- Reactive Proteins
Periodo de tiempo: 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.
12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body weight
Periodo de tiempo: 12 weeks
weight-height scale was used to calculate body weight (kilogram) for all participants before and after intervention.
12 weeks
Body mass index
Periodo de tiempo: 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.
12 weeks
waist circumference
Periodo de tiempo: 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).
12 weeks
Hip circumference
Periodo de tiempo: 12 weeks
Hip circumference was measured by the tape at the level of grater trochanter (centimeter).
12 weeks
waist-hip ratio
Periodo de tiempo: 12 weeks
waist-hip ratio was calculated by dividing waist circumference over hip circumference, before and after the study intervention.
12 weeks
Muscle mass
Periodo de tiempo: 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.
12 weeks
Body fat weight
Periodo de tiempo: 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.
12 weeks
Body fat percentage
Periodo de tiempo: 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.
12 weeks
Visceral fat
Periodo de tiempo: 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.
12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Cairo University

Investigadores

  • Silla de estudio: Abeer ElDeeb, Professor, Cairo University
  • Director de estudio: Samira Swdky, Professor, Al-Azhar University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2025

Finalización primaria (Actual)

15 de julio de 2025

Finalización del estudio (Actual)

30 de julio de 2025

Fechas de registro del estudio

Enviado por primera vez

24 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de junio de 2026

Publicado por primera vez (Actual)

30 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 012/004731

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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