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临床试验/NCT05818293
NCT05818293招募中不适用

Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women

Cairo University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
2
主要终点
EFFECT OF RADIOFRQUENCY ON INSULIN RESISTANCE IN OBESE POST MENOPAUSAL WOMEN EFFECT OF RADIOFRQUENCY ON INSULIN RESISTANCE IN OBESE POST MENOPAUSAL WOMEN effect of radiofrequency on insulin resistance in obese post menopausal women

研究概览

简要总结

insulin resistance as the prime factor linking visceral obesity with adverse metabolic changes. Analysis of abdominal obesity by imaging studies have generally reached the conclusion that it is the excess of intra-abdominal or visceral adipose tissue .Multiple environmental and genetic factors are thought to influence the manifestation of abdominal obesity. The expanded adipose tissue contributes to expose the liver to high concentrations of free fatty acids (FFA), impairing several hepatic metabolic processes leading to hyperinsulinemia .On the other side, there is an increase in the secretion of different adipokines, such as interleukin IL-6 and tumor necrosis factor-α (TNF-α), which also contributes to the insulin-resistant state .

So, RF technology deployed by Vanquish uses oscillating electrical current forcing collisions between charged molecules and ions, which are then transformed into heat. Since fat biophysical characteristics behave like an insulator capable of polarization, it absorbs the high RF-related heat release from the RF applicator driving specific fat necrosis and consequent lipolysis. Patients lay underneath the device while the focused-field radiofrequency heats up the underlying .

详细描述

The eligible participants will be divided into two equal groups included fifty two post-menopausal women. They will be selected randomly from El kalil Ebrahem hospital in Hadaek El Maadi.

Each group will be twenty six women. Group (A) (study group) will receive radiofrequency, medical standard care for insulin resistance and regular diet habits. This group will receive 30 minutes on the abdominal area by radiofrequency, twice per week. The treatment procedure consists of placing the emitting panel over abdomen and flanks close to the skin using a spacer which standardizes distance between the panel and the body surface.

Once it is in supine position, with a pillow under their heads and with their knees in flexion. Initially, the abdominal region of each participant was divided into two equal parts- right and left-with the line Alba as reference.

Group (B) (control group) will receive regular diet habits only.

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
None

盲法说明

will be blind

入排标准

年龄范围
48 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • • All participants post-menopausal from at least 3 years.
  • All participants' ages will be ranged from 48-60 years old.
  • All participants BMI will exceed 30 kg/m
  • All participants waist hip ratio will be equal or more than 0, 89.

排除标准

  • • Surgical liposuction within the last 12 months.
  • Untreated hypo- or hyperthyroidism.
  • Uncontrolled liver, kidney or cardiovascular disease or diabetes.
  • Implanted pacemaker or metal implant.
  • History of thrombophlebitis, any hematological disease.
  • No past or present neurological and musculoskeletal disorders that will have affected health condition.
  • No smoking and drinking habits.
  • No psychological problems.

结局指标

主要结局

EFFECT OF RADIOFRQUENCY ON INSULIN RESISTANCE IN OBESE POST MENOPAUSAL WOMEN EFFECT OF RADIOFRQUENCY ON INSULIN RESISTANCE IN OBESE POST MENOPAUSAL WOMEN effect of radiofrequency on insulin resistance in obese post menopausal women

时间窗: 4 months

RF will use to reduce subcutaneous fat in abdomen and buttocks. he outcome measures to assess the insulin resistance by Homeostasis Model Assessment (HOMA), abdominal obesity by abdominal ultrasound and waist \\hip ratio. 1. The Homeostasis Model Assessment (HOMA) : Is a model of interactions between glucose and insulin dynamics that is then used to predict fasting steady-state glucose and insulin concentrations for a wide range of possible combinations of insulin resistance and β-cell function. The model assumes a feedback loop between the liver and β-cell . 2. Abdominal Ultrasound: To assess abdominal fat for all participants before and after treatment program.

次要结局

未报告次要终点

研究者

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

Shymaa Mohammed Abdo Mohammed

physiotherapist

Cairo University

研究点 (2)

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