Show Positive Effect of Radiofrequancy on Postmenopausal Adipose TissueNCT05895435
THE EFFECT OF RADIOFREQUENCY ON POSTMENOPAUSAL ADIPOSE TISSUE
A study testing radiofrequancy and aerobic exercise in people with Show Positive Effect of Radiofrequancy on Postmenopausal Adipose Tissue, run by Cairo University.
Trial summary
Menopause is associated with a redistribution of adipose tissue towards central adiposity, known to cause insulin resistance. It was found that menopause was associated with changes in adipose tissue phenotype related to metabolic dysfunction. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Show Positive Effect of Radiofrequancy on Postmenopausal Adipose Tissue
- What is being tested?
- radiofrequancy and aerobic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2023to 18 Oct 2023
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1-Their ages will be ranged from 45 to 60 years 2- BMI > 25 kg/m² and < 35 kg/m². 3- Waist circumference more than 88cm
Who cannot join
- 1-Cancer. 2-Renal failure 3-tumors 4-Hepatic diseases 5-skin disease that prevent the use of radiofrequancy
Trial locations and contacts
No sites are listed yet.
About this study
- Menopause is associated with a redistribution of adipose tissue towards central adiposity, known to cause insulin resistance. It was found that menopause was associated with changes in adipose tissue phenotype related to metabolic dysfunction. In subcutaneous adipose tissue (SAT)
- The radiofrequency uses high-frequency electromagnetic waves to produce heat at the cutaneous and the subcutaneous levels. The mechanism of action, through the vibration of water molecules, transforms the electromagnetic energy into thermal. The heat generated by conversion occurs under 30 kHz to 300 MHz, and the most frequently used frequency is set between 0.5 and 1.5 MHz. The RF mechanism of fat reduction occurs by the generation of thermal stimulation of adipocyte metabolism, occurring through enzymatic degradation by lipase-mediated triglycerides, apoptosis, and adipocyte rupture and the objective of study to show the positive effect of radiofrequancy on postmenopausal adipose tissue
Read the detailed description
About 90% of menopausal women experience some amount of weight gain. It is a natural and common aspect of getting older. It occurs because the body mass increases, as a result of fat deposits. However, weight gain associated with menopause typically involves increased amounts of fat around the abdomen. On an average, women gain between 8-10 kilogram between the ages of 45 and 55, the stage in life when menopause occurs. This extra weight generally does not evenly distribute itself throughout a woman's body. The weight tends instead to accumulate around the abdomen or thighs (Singh et al., 2013).
Postmenopausal women are usually troubled by increasing weight and waist circumference caused by obesity and android fat redistribution it is mostly attributed to estrogen depletion though other factors such as chronological aging and decline in physical activity play a significant role. The deleterious health consequences of obesity and visceral fat deposition after menopause encompass a variety of problems; from dyslipidemia and metabolic syndrome to increased risk of cardiovascular disease (CVD), osteoporosis, malignancies and mortality (Stachowiak et al., 2015) This emphasizes the need of effective methods for treating central adiposity in post-menopausal woman. No prior studies have investigated the effect of radiofrequency on adipose tissue. So this may add a new physical therapy method for treating this problem.
- Being tested
- radiofrequancy, aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequancyDevice
- Power of device: 150 W
- Duration of the session: 40 minutes
- Frequency: 2 sessions per week for 8 week.
- Heating temperature: According to patient tolerance.
aerobic exerciseOther
The program include five minutes for warming-up in the form of range of motion and stretching exercises, thirty minutes of walking on treadmill with high speed (60-70% of maximum heart rate) and five minutes of cooling down (on treadmill with low speed and without inclination
| Study group | Role | What they receive |
|---|---|---|
| first group | Experimental | Group (A) (Control Group):
It will be consisted of 30 patients who will receive aerobic exercise and diet for 8 successive weeks 2 sessions per week. Receives: Other: aerobic exercise |
| second group | Experimental | Group (B) (Study Group):
It will be consisted of 30 patients who will receive aerobic exercise and diet and radiofrequency for 8 successive weeks 2 sessions per week. Receives: Device: radiofrequancy; Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
total cholestrol and HDL and LDL and triglycerides and VLDL by blood analysis
measure before and after tratement programm
Measured: 8 week
Secondary outcomes (3)
waist circumferance using tape measurment
measure before and after tratement
Measured: 8 week
body mass index
measure before and after tratement
Measured: 8 week
weight
measure before and after tratement
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start31 May 2023 (estimated)
- Primary completion15 Oct 2023 (estimated)
- Study completion18 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Show Positive Effect of Radiofrequancy on Postmenopausal Adipose TissueStudies 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
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Adel Elasyed Darahem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895435
- Sponsor's protocol ID
- the effect of radiofrequancy
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guthrie JR, Dennerstein L, Taffe JR, Donnelly V. Health care-seeking for menopausal problems. Climacteric. 2003 Jun;6(2):112-7.
PubMed 12841881
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF RADIOFREQUENCY ON POSTMENOPAUSAL ADIPOSE TISSUE
- ClinicalTrials.gov ID
- NCT05895435
- Acronym / sponsor ID
- the effect of radiofrequancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 May 2023 (estimated)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 18 Oct 2023 (estimated)
- First posted
- 8 Jun 2023 (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.
- Menopause is associated with a redistribution of adipose tissue towards central adiposity, known to cause insulin resistance. It was found that menopause was associated with changes in adipose tissue phenotype related to metabolic dysfunction. In subcutaneous adipose tissue (SAT)
- The radiofrequency uses high-frequency electromagnetic waves to produce heat at the cutaneous and the subcutaneous levels. The mechanism of action, through the vibration of water molecules, transforms the electromagnetic energy into thermal. The heat generated by conversion occurs under 30 kHz to 300 MHz, and the most frequently used frequency is set between 0.5 and 1.5 MHz. The RF mechanism of fat reduction occurs by the generation of thermal stimulation of adipocyte metabolism, occurring through enzymatic degradation by lipase-mediated triglycerides, apoptosis, and adipocyte rupture and the objective of study to show the positive effect of radiofrequancy on postmenopausal adipose tissue
Detailed description
About 90% of menopausal women experience some amount of weight gain. It is a natural and common aspect of getting older. It occurs because the body mass increases, as a result of fat deposits. However, weight gain associated with menopause typically involves increased amounts of fat around the abdomen. On an average, women gain between 8-10 kilogram between the ages of 45 and 55, the stage in life when menopause occurs. This extra weight generally does not evenly distribute itself throughout a woman's body. The weight tends instead to accumulate around the abdomen or thighs (Singh et al., 2013).
Postmenopausal women are usually troubled by increasing weight and waist circumference caused by obesity and android fat redistribution it is mostly attributed to estrogen depletion though other factors such as chronological aging and decline in physical activity play a significant role. The deleterious health consequences of obesity and visceral fat deposition after menopause encompass a variety of problems; from dyslipidemia and metabolic syndrome to increased risk of cardiovascular disease (CVD), osteoporosis, malignancies and mortality (Stachowiak et al., 2015) This emphasizes the need of effective methods for treating central adiposity in post-menopausal woman. No prior studies have investigated the effect of radiofrequency on adipose tissue. So this may add a new physical therapy method for treating this problem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group | Experimental | Other: aerobic exerciseGroup (A) (Control Group): It will be consisted of 30 patients who will receive aerobic exercise and diet for 8 successive weeks 2 sessions per week. |
| second group | Experimental | Device: radiofrequancy, Other: aerobic exerciseGroup (B) (Study Group): It will be consisted of 30 patients who will receive aerobic exercise and diet and radiofrequency for 8 successive weeks 2 sessions per week. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1-Their ages will be ranged from 45 to 60 years 2- BMI > 25 kg/m² and < 35 kg/m². 3- Waist circumference more than 88cm
Key exclusion criteria (1 listed)
- 1-Cancer. 2-Renal failure 3-tumors 4-Hepatic diseases 5-skin disease that prevent the use of radiofrequancy
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 |
|---|---|---|
| radiofrequancy* Power of device: 150 W * Duration of the session: 40 minutes * Frequency: 2 sessions per week for 8 week. * Heating temperature: According to patient tolerance. | Device | second group |
| aerobic exerciseThe program include five minutes for warming-up in the form of range of motion and stretching exercises, thirty minutes of walking on treadmill with high speed (60-70% of maximum heart rate) and five minutes of cooling down (on treadmill with low speed and without inclination | Other | first group, second group |
Primary outcome
total cholestrol and HDL and LDL and triglycerides and VLDL by blood analysis
Time frame: 8 week
measure before and after tratement programm
3 secondary outcomes
waist circumferance using tape measurment
Time frame: 8 week
body mass index
Time frame: 8 week
weight
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 12841881Guthrie JR, Dennerstein L, Taffe JR, Donnelly V. Health care-seeking for menopausal problems. Climacteric. 2003 Jun;6(2):112-7.
- data obtain through the study may be provided to a qualified resarcherLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequancy and aerobic exercise in people with Show Positive Effect of Radiofrequancy on Postmenopausal Adipose Tissue, run by Cairo University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mahmoud adel darahem (01028911100, mahmouddarahem2023@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total cholestrol and HDL and LDL and triglycerides and VLDL by blood analysis (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05895435, which also lists 1 linked publication.
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 8 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.