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

Not Applicable

Recruiting

• Conditions: Central Obesity

• Registration Number: NCT06729203
• Lead Sponsor: Cairo University

Brief 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.

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-08
• Last Update Submitted: 2024-12-08
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-02-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HOMA ir	"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 Outcome Measures

Name	Time	Method
Skin fold by caliper	"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
Waist circumference (WC) by tape measurement	"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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt