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临床试验/NCT06729203
NCT06729203招募中不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
HOMA ir

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •• 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/m
  • •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.

研究组 & 干预措施

Group A

Experimental

this group receive ultrasound cavitation on abdominal muscles

干预措施: Ultrasound cavitation (Device)

Group B

Active Comparator

received aerobic exercises and low caloric diet treatment.

干预措施: Exercise (Other)

结局指标

主要结局

HOMA ir

时间窗: "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.

次要结局

  • 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")

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Saeed Khalil Shazly

physiotherapist

Cairo University

研究点 (1)

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