Central ObesityNCT06729203
Effect of Ultrasound Cavitation on Insulin Resistance in Patients with Central Obesity in Female
A study testing Ultrasound cavitation and Exercise in people with Central Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study was to investigate the effect of ultrasound cavitation on insulin resistance, HbA1c and skin fold in patients with abdominal central obesity. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Central Obesity
- What is being tested?
- Ultrasound cavitation and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects with central obesity.
- Female participants aged between 25 to 40 years.
- Body Mass Index (BMI) ranged from 30 to 35 kg/m2 as high BMI indicates more obesity and central obesity.
- Waist circumference greater than 88 cm, indicative of abdominal obesity.
- Diagnosed with insulin resistance (HOMA-IR > 2.9).
- Sedentary lifestyle, defined as engaging in less than 150 minutes of moderate-intensity physical activity per week.
- Willingness to provide informed consent and comply with study procedures.
Who cannot join
- • Subjects diagnosed with DM (HbA1c more than 6.5%).
- History of metabolic disorders such as type 1 diabetes or thyroid disorders.
- Subjects with BMI less than 30 kg/m2.
- Subjects diagnosed with heart disease, liver as well as kidney diseases.
- Subjects who take oral contraceptives.
- Subjects with gestational Diabetes.
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- Pregnant or breastfeeding women were excluded from the study.
- Use of weight-loss medications or supplements within the past six months.
- Previous surgical procedures for weight loss or body contouring.
- Contraindications to ultrasound therapy (e.g., metal implants in the abdomen, active skin infections).
- Participation in another clinical trial within the last three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, Giza Governorate, 3753450
Cairo university, ayasaeedpt@gmail.com
About this study
The purpose of this study was to investigate the effect of ultrasound cavitation on insulin resistance, HbA1c and skin fold in patients with abdominal central obesity.
Read the detailed description
Few researchers have detected the effects of ultrasonic cavitation on insulin resistance in subjects with central obesity. However, there were many conflicts and no clear evidence in the literature concerning the superiority of cavitation on body contour adjustment. Consequently, this study aimed to investigate the effects of ultrasound cavitation, aerobic exercise and a low-calorie dietary program on insulin resistance and total plasma HOMA ir and body contouring in female with abdominal obesity.
- Conditions
- Central Obesity
- Being tested
- Ultrasound cavitation, Exercise
- Keywords
- central obesity, ultrasound cavitation, insulin resistance, HOMA ir
- Medical subject headings
- Obesity, Abdominal, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound cavitationDevice
Also called Ultrasound Fat Cavitation (USFC)
Ultrasound Fat Cavitation (USFC) is the method in handling obesity, especially in destroying fat and shaping a particular part of the body. As one of the non-surgical correction methods, USFC is preferred at decreasing the risk of complications due to obesity.
ExerciseOther
Also called aerobic exercise
The female will stand on the cushioned tread and grasp by her both hands the two arms of the treadmill. Treadmill will adjust to apply moderate intensity training. It was used for 30 minutes divided into five-minutes warming up, twenty-minutes active exercise and five-minutes cooling down and it was used twice a week for twelve weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | this group receive ultrasound cavitation on abdominal muscles Receives: Device: Ultrasound cavitation |
| Group B | Active comparator | received aerobic exercises and low caloric diet treatment. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA ir
This study will evaluate changes in HOMA-IR from baseline to assess improvements in insulin sensitivity because of the ultrasound cavitation intervention.
Measured: "From enrollment to the end of treatment at 8 weeks"
Secondary outcomes (2)
Skin fold by caliper
The skinfold measurements will be taken using a Lange Skinfold Caliper, which provides accurate and reliable readings
Measured: "From enrollment to the end of treatment at 8 weeks"
Waist circumference (WC) by tape measurement
Waist circumference (WC) is an essential anthropometric measure used to evaluate abdominal obesity. It serves as an indicator of visceral fat, which is associated with a higher risk of metabolic disorders, including insulin resistance, type 2 diabetes, and cardiovascular diseases. By measuring waist circumference.
Measured: "From enrollment to the end of treatment at 8 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Dec 2025 (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
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Saeed Khalil Shazly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729203
- Sponsor's protocol ID
- 012/005421
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Cavitation on Insulin Resistance in Patients with Central Obesity in Female
- ClinicalTrials.gov ID
- NCT06729203
- Acronym / sponsor ID
- 012/005421
- Conditions
- Central Obesity
- Keywords
- central obesity, ultrasound cavitation, insulin resistance, HOMA ir
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Dec 2024 (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.
The purpose of this study was to investigate the effect of ultrasound cavitation on insulin resistance, HbA1c and skin fold in patients with abdominal central obesity.
Detailed description
Few researchers have detected the effects of ultrasonic cavitation on insulin resistance in subjects with central obesity. However, there were many conflicts and no clear evidence in the literature concerning the superiority of cavitation on body contour adjustment. Consequently, this study aimed to investigate the effects of ultrasound cavitation, aerobic exercise and a low-calorie dietary program on insulin resistance and total plasma HOMA ir and body contouring in female with abdominal obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Ultrasound cavitationthis group receive ultrasound cavitation on abdominal muscles |
| Group B | Active comparator | Other: Exercisereceived aerobic exercises and low caloric diet treatment. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female subjects with central obesity.
- Female participants aged between 25 to 40 years.
- Body Mass Index (BMI) ranged from 30 to 35 kg/m2 as high BMI indicates more obesity and central obesity.
- Waist circumference greater than 88 cm, indicative of abdominal obesity.
- Diagnosed with insulin resistance (HOMA-IR > 2.9).
Key exclusion criteria (11 listed)
- • Subjects diagnosed with DM (HbA1c more than 6.5%).
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 |
|---|---|---|
| Ultrasound cavitationAlso: Ultrasound Fat Cavitation (USFC)Ultrasound Fat Cavitation (USFC) is the method in handling obesity, especially in destroying fat and shaping a particular part of the body. As one of the non-surgical correction methods, USFC is preferred at decreasing the risk of complications due to obesity. | Device | Group A |
| ExerciseAlso: aerobic exerciseThe female will stand on the cushioned tread and grasp by her both hands the two arms of the treadmill. Treadmill will adjust to apply moderate intensity training. It was used for 30 minutes divided into five-minutes warming up, twenty-minutes active exercise and five-minutes cooling down and it was used twice a week for twelve weeks. | Other | Group B |
Primary outcome
HOMA ir
Time frame: "From enrollment to the end of treatment at 8 weeks"
This study will evaluate changes in HOMA-IR from baseline to assess improvements in insulin sensitivity because of the ultrasound cavitation intervention.
2 secondary outcomes
Skin fold by caliper
Time frame: "From enrollment to the end of treatment at 8 weeks"
Waist circumference (WC) by tape measurement
Time frame: "From enrollment to the end of treatment at 8 weeks"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound cavitation and Exercise 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 11 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Saeed Shazly, Master degree (00201096841660, aya_saeedpt@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA ir (time frame: "From enrollment to the end of treatment at 8 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 11 Dec 2024.