Central ObesityNCT06024018
Effect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese Men
A study testing high intensity electromagnetic technology device, diet restriction, and walking and diet restriction and walking in people with Central Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
high intensity focused electromagnetic technology's secondary effects are observed in the fat (adipose). within 8 h of a treatment session, apoptotic levels in adipose increased 91.7%.8 In addition, after the application of the high intensity electromagnetic technique, there is an increase in the rapid release of free… Read more about this study
- Who is it for?
- Ages 40 to 50 years, men only
- Conditions the study is for
- Central Obesity
- What is being tested?
- high intensity electromagnetic technology device, diet restriction, and walking and diet restriction and walking
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Dec 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 40 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- men with central obesity
- BMI 30-34.9 kg/m2
Who cannot join
- metabolic /cardiovascular, pulmonary illnesses, musculoskeletal/neurological illness, autoimmune/psychological illnesses
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unoversity
Giza
Ali Ismail, lecturer, 01005154209, allooka2012@gmail.com
EBTEHAL ATEF RAMADAN AFYA, 020 102 466 6329, dr.ebtehalpt@yahoo.com
About this study
Official title: Efficacy of High Intensity Electromagnetic Body Shaping in Obese Men
high intensity focused electromagnetic technology's secondary effects are observed in the fat (adipose). within 8 h of a treatment session, apoptotic levels in adipose increased 91.7%.8 In addition, after the application of the high intensity electromagnetic technique, there is an increase in the rapid release of free fatty acids, so it can be used in weight loss
Read the detailed description
sixty obese males will be grouped to: first group (30 males) and second group (30 males). first and second groups will undergo dietary caloric restriction (i.e low calorie diet) and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. only the first group will will undergo high intensity electromagnetic technique on abdomen of males which will be 3 sessions per week for 3 months
- Conditions
- Central Obesity
- Being tested
- high intensity electromagnetic technology device, diet restriction, and walking, diet restriction and walking
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity electromagnetic technology device, diet restriction, and walkingDevice
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months
diet restriction and walkingBehavioural
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| first group | Experimental | thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months Receives: Device: high intensity electromagnetic technology device, diet restriction, and walking |
| second group | Active comparator | thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Receives: Behavioral: diet restriction and walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
subcutaenous abdominal fat thickness
it will be measured using ultrasonography
Measured: 12 weeks
Secondary outcomes (11)
visceral abdominal fat thickness
it will be measured using ultrasonography
Measured: 12 weeks
body mass index
it will be measured at morning with empty stomach and bladder
Measured: 12 weeks
waist circumference
it will be measured using inelastic tape
Measured: 12 weeks
cortisol
it is a stress hormone
Measured: 12 weeks
high density lipoprotein
it will be measured in serum
Measured: 12 weeks
low density lipoprotein
it will be measured in serum
Measured: 12 weeks
triglycerides
it will be measured in serum
Measured: 12 weeks
cholesterol
it will be measured in serum
Measured: 12 weeks
appearance of abdomen subscale of Body Q questionnaire
BODY-Q provides a set of scales focusing on topics that are relevant to weight
Measured: 12 weeks
health related-quality-of-life subscale of Body Q questionnaire
it provids questions related to body image , physical function , psychological function , sexual function
Measured: 12 weeks
eating related concerns subscale of Body Q questionnaire
it provids questions related to eating behavior , expectations weight loss
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 posted5 Sep 2023
- Study start1 Jun 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024018
- Sponsor's protocol ID
- P.T.REC/012/003755
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 5 Sep 2023
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Intensity Electromagnetic Body Shaping in Obese Men
- ClinicalTrials.gov ID
- NCT06024018
- Acronym / sponsor ID
- P.T.REC/012/003755
- Conditions
- Central Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Sep 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.
high intensity focused electromagnetic technology's secondary effects are observed in the fat (adipose). within 8 h of a treatment session, apoptotic levels in adipose increased 91.7%.8 In addition, after the application of the high intensity electromagnetic technique, there is an increase in the rapid release of free fatty acids, so it can be used in weight loss
Detailed description
sixty obese males will be grouped to: first group (30 males) and second group (30 males). first and second groups will undergo dietary caloric restriction (i.e low calorie diet) and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. only the first group will will undergo high intensity electromagnetic technique on abdomen of males which will be 3 sessions per week for 3 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group | Experimental | Device: high intensity electromagnetic technology device, diet restriction, and walkingthirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months |
| second group | Active comparator | Behavioral: diet restriction and walkingthirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- men with central obesity
- BMI 30-34.9 kg/m2
Key exclusion criteria (1 listed)
- metabolic /cardiovascular, pulmonary illnesses, musculoskeletal/neurological illness, autoimmune/psychological illnesses
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 |
|---|---|---|
| high intensity electromagnetic technology device, diet restriction, and walkingthirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months | Device | first group |
| diet restriction and walkingthirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. | Behavioural | second group |
Primary outcome
subcutaenous abdominal fat thickness
Time frame: 12 weeks
it will be measured using ultrasonography
11 secondary outcomes
visceral abdominal fat thickness
Time frame: 12 weeks
body mass index
Time frame: 12 weeks
waist circumference
Time frame: 12 weeks
cortisol
Time frame: 12 weeks
high density lipoprotein
Time frame: 12 weeks
low density lipoprotein
Time frame: 12 weeks
triglycerides
Time frame: 12 weeks
cholesterol
Time frame: 12 weeks
appearance of abdomen subscale of Body Q questionnaire
Time frame: 12 weeks
health related-quality-of-life subscale of Body Q questionnaire
Time frame: 12 weeks
eating related concerns subscale of Body Q questionnaire
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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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.
Ali MA Ismail, lecturer study director
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 high intensity electromagnetic technology device, diet restriction, and walking and diet restriction and walking in people with Central 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 2 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 5 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subcutaenous abdominal fat thickness (time frame: 12 weeks). 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 5 Sep 2023.