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

December 8, 2024 updated by: Aya Saeed Khalil Shazly, Cairo University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
this group receive ultrasound cavitation on abdominal muscles
Device: 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.
Other Names:
  • Ultrasound Fat Cavitation (USFC)
Active Comparator: Group B
received aerobic exercises and low caloric diet treatment.
Other: 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.
Other Names:
  • aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
"From enrollment to the end of treatment at 8 weeks"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
"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"
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.
"From enrollment to the end of treatment at 8 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 8, 2024

First Submitted That Met QC Criteria

December 8, 2024

First Posted (Estimated)

December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 8, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012/005421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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