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NCT Number: NCT06729203

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

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.

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Key information

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Giza Governorate, 3753450, Egypt

Location status: Recruiting

Location contact

Cairo university

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasound cavitation

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.

Other names: Ultrasound Fat Cavitation (USFC)

Exercise

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.

Other names: aerobic exercise

Primary outcomes

  1. 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.

Secondary outcomes

  1. Skin fold by caliper

    Time frame: "From enrollment to the end of treatment at 8 weeks"

    The skinfold measurements will be taken using a Lange Skinfold Caliper, which provides accurate and reliable readings

  2. Waist circumference (WC) by tape measurement

    Time frame: "From enrollment to the end of treatment at 8 weeks"

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Saeed Shazly, Master degree

CONTACT

[email protected]

00201096841660

Islam Hassan Fayed, Doctorate

CONTACT

[email protected]

00201097279742

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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