ObesityNCT07676279
Effect of Cryolipolysis on Inflammatory Factors in Obese Postmenopausal Women
A study testing Cryolipolysis and aerobic exercise in people with Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Cryolipolysis and aerobic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women.
Read the 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.
- Conditions
- Obesity
- Being tested
- Cryolipolysis, aerobic exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryolipolysisDevice
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.
aerobic exerciseOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cryolipolysis; Other: aerobic exercise |
| aerobic exercise group | Active comparator | The participants received aerobic exercises on treadmill only for 30 minutes/ 2sessions per week for 12 weeks. Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (9)
Body weight
weight-height scale was used to calculate body weight (kilogram) for all participants before and after intervention.
Measured: 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.
Measured: 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).
Measured: 12 weeks
Hip circumference
Hip circumference was measured by the tape at the level of grater trochanter (centimeter).
Measured: 12 weeks
waist-hip ratio
waist-hip ratio was calculated by dividing waist circumference over hip circumference, before and after the study intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jan 2025
- Primary completion15 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Elsayed Mohamed, Cairo University
- Investigators
- Samira Swdky, Professor, Study director, Al-Azhar UniversityAbeer ElDeeb, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676279
- Sponsor's protocol ID
- 012/004731
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryolipolysis on Inflammatory Factors in Obese Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07676279
- Acronym / sponsor ID
- 012/004731
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryolipolysis and aerobic exercise group | Experimental | Device: Cryolipolysis, Other: aerobic exerciseThe 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. |
| aerobic exercise group | Active comparator | Other: aerobic exerciseThe participants received aerobic exercises on treadmill only for 30 minutes/ 2sessions per week for 12 weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryolipolysisVacuum 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. | Device | Cryolipolysis and aerobic exercise group |
| aerobic exerciseParticipants 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) | Other | Cryolipolysis and aerobic exercise group, aerobic exercise group |
Primary outcome
Serum interleukin-6
Time frame: 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.
C- Reactive Proteins
Time frame: 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.
9 secondary outcomes
Body weight
Time frame: 12 weeks
Body mass index
Time frame: 12 weeks
waist circumference
Time frame: 12 weeks
Hip circumference
Time frame: 12 weeks
waist-hip ratio
Time frame: 12 weeks
Muscle mass
Time frame: 12 weeks
Body fat weight
Time frame: 12 weeks
Body fat percentage
Time frame: 12 weeks
Visceral fat
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samira Swdky, Professor study director
Al-Azhar University
Abeer ElDeeb, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryolipolysis and aerobic exercise in people with Obesity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum interleukin-6 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.