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Recruiting NCT06729203

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

No phase Interventional Central Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound cavitation, Exercise.
Who it may be relevant to
Registry conditions: Central Obesity. Basic parameters: 25 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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 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.

Primary outcome measures

  • HOMA ir [Time frame: "From enrollment to the end of treatment at 8 weeks"]
Secondary outcome measures (2)
  • 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"]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Giza

Identifiers

NCT: NCT06729203 · 012/005421

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗