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临床试验/NCT06377358
NCT06377358已完成不适用

Lipolysis of Visceral Reserve Fat Using Tecar Therapy: Anthropometric, Biochemical and NMR Imaging Study.

CAPENERGY MEDICAL, SL1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
C Reactive Protein Levels

研究概览

简要总结

The Scope of this study is to assess the visceral and subcutaneous fat loss in patients having Tecar (Radiofrequency) Therapy and its effects on other anthropometric variables, adipokines and inflammation.

20 obese patients will be treated with Tecar Therapy (Radiofrequency). Each patient will have 4 active, automatic plates placed on the abdomen (200 cm2 per plate), two on the right side of the midline and two on the left side. Energy will be applied for 50 minutes, controlling the temperature. Subsequently, 15 minutes of Capacitive and Resistive manual electrodes will be applied to the abdomen, simultaneously, 20 minutes of Lymphatic Drainage placing one active plate in the foot and the other in the lumbo-dorsal area. Patients will be informed that they will only feel comfortable warmth. Five sessions will be applied from Monday to Friday resting Saturday and Sunday, for 2 weeks. Total 10 sessions.

Subcutaneous and visceral fat will be measured by MRI. Anthropometric variables (Body Mass Index, Waist to Hip ratio and skinfold) will be also measured.

Metabolic and inflammatory effects of the RF treatment will be evaluated measuring adipokines (Leptin, adiponectin and resistin) as well as citokines (IL-6, TNF-a and C reactive Protein).

Results will be analyzed using the SPSS statistics package. A Kolmogorov-Smirnov test will be applied, if the data behaves normally, parametric tests will be applied. If not, non-parametric tests will be performed. The differences between proportions will be analyzed using Fischer's exact test. The differences between the medians will be assessed using the Student's t-test for paired samples and independent samples.

详细描述

Radiofrequency (RF) is an inexpensive, virtually side-effect-free, well-tolerated method that reduces belly fat. RF is a form of high-frequency electromagnetic energy that works by heating tissues (Tecar Therapy). Its action in deeper tissues (subcutaneous layer) aims to increase cellular metabolism. When applied to tissues, RF generates oscillating magnetic fields that move electrically charged particles, producing heat in the tissues, and the amount of heat produced depends on the resistance (bioimpedance) of the target tissue. Electrical energy is converted into thermal energy. There is evidence of a transient RF effect on autonomic homeostasis with no known negative effects. This autonomic response to RF is reflected in a thermoregulatory vasomotor mechanism, in changes in chemoreceptor activity, and even in fluctuations in the renin-angiotensin system, responses related to the control of energy metabolism. The elevation of tissue temperature appears to be sufficient to activate the sympathetic branch of the Autonomic Nervous System, leading to the release of catecholamines (adrenaline and noradrenaline), which are the trigger to activate lipolysis. Lipolysis is the reversible biochemical process where triglyceride catabolism is stored. This process culminates in the generation of non-esterified fatty acids and glycerol. Fatty acids released into the bloodstream can be used as a substrate to produce energy.

Ex vivo human skin cultures after completion of the RF treatment series showed a significant effect on subcutaneous adipocytes. Adipocyte cells were observed to have altered morphology and increased expression of the apoptosis marker, APAF-1, suggesting that induced apoptosis is the mechanism of action. Adipocyte apoptosis results in the release of triglycerides from disintegrated cell membranes, but in a delayed and gradual manner, allowing for slow and safe elimination through the interstitial space, and subsequent lipid transport systems, lymphatic systems, and other metabolic functions. There was no evidence of necrosis or inflammatory changes observed in adipocytes after treatments with this new RF device.

Obesity causes an increase in adipose tissue and an increased infiltration of inflammatory cells into that tissue with a predominance of pro-inflammatory cytokines resulting in the development of a chronic low-intensity inflammatory state.

Adipocytolysis is a term used to describe the phenomena caused by non-surgical techniques (cytolytic methods) for the reduction of localized fat, in which lipids could be broken or solubilized through the partial or total rupture of adipocytes, destroying their plasma membrane.

Frequencies around 1 MHz are used, which are the ones that act most effectively on the cell, but with a high power, adjustable temperature and a treatment area greater than 200 cm2, which allows it to mechanically destroy the adipose cells, with greater effectiveness in the subcutaneous adipose tissue without damaging the skin. blood, vessels, nerves, or connective tissues. Lipids are gradually eliminated through the lymphatic system, reducing tissue volume.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Refusal to sign the informed consent.
  • Pregnancy.
  • Patients with metal prostheses.
  • Presence of active infection.
  • Patients with oncological history with chemotherapy treatments or radiotherapy.
  • Presence of diabetes.
  • Presence of metabolic disease.
  • Presence of arterial hypertension.

结局指标

主要结局

C Reactive Protein Levels

时间窗: 3 months

Changes in serum/plasma C reactive Protein (mg/L) after Tecar Therapy treatment.

Visceral Fat Loss (cm3)

时间窗: 3 months

Measurement of Visceral fat loss (cm3) after Tecar Therapy treatment.

Visceral Fat Loss (g)

时间窗: 3 months

Measurement of Visceral fat loss (g) after Tecar Therapy treatment.

Subcutaneous Fat Loss (cm3)

时间窗: 3 months

Measurement of subcutaneous fat loss (cm3) after Tecar Therapy treatment.

Interleukin 6 Levels

时间窗: 3 months

Changes in serum/plasma levels of Interleukin 6 (pg/mL) after Tecar Therapy treatment.

Subcutaneous Fat Loss (g)

时间窗: 3 months

Measurement of subcutaneous fat loss (g) after Tecar Therapy treatment.

Tumor Necrosis Factor Alfa

时间窗: 3 months

Changes in serum/plasma levels of Tumor Necrosis Factor alfa (pg/mL) after Tecar Therapy treatment.

Leptin Levels

时间窗: 3 months

Changes in serum/plasma levels of leptin after Tecar Therapy treatment.

Adiponectin Levels

时间窗: 3 months

Changes in serum/plasma levels of adiponectin after Tecar Therapy treatment.

Resistin Levels

时间窗: 3 months

Changes in serum/plasma levels of resistin after Tecar Therapy treatment.

Total Cholesterol Changes

时间窗: 3 months

Measurement of serum total cholesterol (mg/dL) after Tecar Therapy treatment.

Total Triglycerides Changes

时间窗: 3 months

Measurement of serum total triglycerides (mg/dL) after Tecar Therapy treatment.

LDL Cholesterol Changes

时间窗: 3 months

Measurement of serum LDL Cholesterol (mg/dL) after Tecar Therapy treatment.

HDL Cholesterol Changes

时间窗: 3 months

Measurement of serum HDL Cholesterol (mg/dL) after Tecar Therapy treatment.

Glucose

时间窗: 3 months

Measurement of Glucose (mg/dL) after Tecar Therapy treatment.

次要结局

  • Body Mass Index Loss(3 months)
  • Waist to Hip Ratio (WHR-unitless) Loss(3 months)
  • Skinfold Thickness (mm)(3 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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