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

NCT06729203 | Recruiting DMC

• 1 other identifier: 012/005421
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Obesity

Keywords

central obesity; ultrasound cavitation; insulin resistance; HOMA ir

Outcome Measures

Primary Outcomes (1)

• HOMA ir

  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 Outcomes (2)

• Skin fold by caliper

  "From enrollment to the end of treatment at 8 weeks"

• Waist circumference (WC) by tape measurement

  "From enrollment to the end of treatment at 8 weeks"

Study Arms (2)

Group A

EXPERIMENTAL

this group receive ultrasound cavitation on abdominal muscles

Device: Ultrasound cavitation

Group B

ACTIVE COMPARATOR

received aerobic exercises and low caloric diet treatment.

Other: Exercise

Interventions

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.

Also known as: Ultrasound Fat Cavitation (USFC)

Group A

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.

Also known as: aerobic exercise

Group B

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Giza Governorate, 3753450, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Aya Saeed Shazly, Master degree

CONTACT

00201096841660; aya_saeedpt@yahoo.com

Islam Hassan Fayed, Doctorate

CONTACT

00201097279742; islamfayed@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

EG (1)