Effect of Ultrasound Cavitation on Insulin Resistance in Patients with Central Obesity in Female

NCT ID: NCT06729203

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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

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Central Obesity

Keywords

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central obesity ultrasound cavitation insulin resistance HOMA ir

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

this group receive ultrasound cavitation on abdominal muscles

Group Type EXPERIMENTAL

Ultrasound cavitation

Intervention Type DEVICE

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.

Group B

received aerobic exercises and low caloric diet treatment.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

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.

Interventions

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Ultrasound cavitation

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Ultrasound Fat Cavitation (USFC) aerobic exercise

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* • 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.
* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Aya Saeed Khalil Shazly

physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Giza, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aya Saeed Shazly, Master degree

Role: CONTACT

Phone: 00201096841660

Email: [email protected]

Islam Hassan Fayed, Doctorate

Role: CONTACT

Phone: 00201097279742

Email: [email protected]

Facility Contacts

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Cairo university

Role: primary

Other Identifiers

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012/005421

Identifier Type: -

Identifier Source: org_study_id