Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy.

July 16, 2025 updated by: CAPENERGY MEDICAL, SL

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

This procedure has been used quite effectively in aesthetics to reduce subcutaneous fat.

Inflammation is an orderly sequence of events designed to maintain homeostasis of organs and tissues. Chronic inflammation that lasts a long time and is characterized by the presence of lymphocytes and macrophages and the proliferation of blood vessels and connective tissue. This is considered a characteristic feature of metabolic syndrome, characterized by the secretion of inflammatory adipokines usually from adipose tissue, such as leptin, interleukin (IL-6), tumor necrosis factor α (TNF-α), monocyte chemoattractant protein. 1 (MCP-1) and resistin. Obesity, which is a feature of metabolic syndrome, was associated with chronic inflammation in obese subjects. Several inflammatory indicators are linked to obesity and shed light on the associated health complications. Inflammatory indicators include IL-6 and C-reactive protein (CRP) as inflammatory markers and adiponectin as an anti-inflammatory marker.

Sustained inflammation is considered a major risk factor for developing many diseases, including cardiovascular disease, metabolic syndrome, diabetes, and cancer. As a risk factor, obesity predisposes to a pro-inflammatory state through the increase of inflammatory mediators IL-6 and TNF-α, and reduced levels of adiponectin, which has a totally anti-inflammatory function. The inflammatory state followed by vascular and endothelial dysfunction is characterized by a decrease in nitric oxide and an increase in reactive oxygen species leading to oxidative stress. Both states of oxidative stress and inflammation initiate atherosclerosis, hypertension, alteration of metabolic markers, and thus major adverse cardiovascular events. Hence the importance of studying these markers before and after treatment.

RF treatment induces an increase in the apoptotic index in adipocytes 1 hour after RF treatment. This is accompanied by a maximum temperature of 45°C in the grease layer. Skin surface temperatures remain substantially lower than fat temperatures.

While computed tomography (CT) is the most commonly used imaging modality for measuring abdominal fat, magnetic resonance imaging (MRI) has similar accuracy. An advantage of MRI is the absence of exposure to ionizing radiation, a limitation that restricts the use of CT in children and adolescents. In addition, the MRI method for quantifying abdominal adiposity is effective, allowing imaging within 5 minutes. Magnetic resonance imaging can provide reliable and good quality images for visceral and subcutaneous quantification.

OBJECTIVES MAIN OBJECTIVE. To evaluate the effect of high-power resistive capacitive radiofrequency on the decrease of visceral and subcutaneous fat and changes in the lipid profile and glucaemia, serum adipokine and inflammation markers.

SIDE OBJECTIVES. To evaluate and the decrease in abdominal circumferente measured by anthropometric tape measure, Body Mass Index, Waist-to-Hip Ratio and skinfold before and after RF treatment.

METHODOLOGY At the inclusion visit, the patient will be given the information sheet and, if they agree, they will be asked to sign the informed consent. Once included in the study, they will be randomly assigned to one of the two study groups in order of consecutive inclusion.

The project has been aprroved by the Ethics Committee of the Autonomous University of Barcelona UAB.

Sample size Calculation The aim of this study was to assess the difference between a decrease in the diameter of the abdominal circumference in a group of women, before and after radiofrequency treatment. The aim is to be able to declare a difference of 2 points or more as significant, taking the SD from published research that gives around 8.0 with a confidence level of 95%, a power of 80% and a correlation coefficient of 0.70 between the values of abdominal circumference before and after treatment. These are taken from the article published by Duarte et al. in 2015, and the following results are obtained according to EPIDATA: 15 pairs of data will then be taken: Before and after the application of RF.

TREATMENT 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.

MEASUREMENTS (Technical details for primary and secondary outcomes)

  • The adipose tissue volumes (cm3) of each compartment were calculated by adding the relevant voxel counts and multiplying by the voxel dimensions in cubic centimeters (cm3). The volume of adipose tissue for the entire abdomen was calculated by multiplying the volumes of adipose tissue from each slice by the sum of the thickness of the slice (5 mm) and the distance between slices. This analysis provides a direct measurement of adipose tissue volume. Adipose tissue in grams is calculated from the following formula:
  • Fat mass (g) = Adipose tissue volume cm3 x 0.66 g/cm3
  • Body Mass Index is calculated as follows: Body Weight (Kg) ÷ Height (m2)
  • Waist-to-Hip Ratio: According to World Health Organization guidelines, the waist should be measured at the midpoint between the last palpable rib and the top of the iliac crest (upper edge of the pelvis). The hip should be measured at the point of maximum circumference. Both measures should be taken immediately after the air in the lungs is exhaled. The caliper takes the thickness of the abdominal wall at 5 cm in an oblique line towards the navel on the right and left side.
  • Subcutaneous and visceral fat: will be measured using, in addition to the MRI method, an Inbody electrical impedance equipment, before ant after treatment.
  • The skinfold thickness will be measured with a calliper.
  • Biochemical parameters: fasting blood will be drawn from the patients, to obtain serum and EDTA-plasma, frozen until Assays. Interlukin-6, Tumor Necrosis Factor-alpha, leptin, adiponectin, resistin and ultrasensitive C-reactive protein will be determined By ELISA by inmmuneassays.

STATISTICAL ANALYSIS The statistical analysis of the results will be performed using the Software Package for Social Sciences (SPSS 24.0.).

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Inneo Terapia Despi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Men and women.
  • Age from 20 to 80 years.
  • Waist circumference > 102 cm in men and > 88 cm in women.
  • BMI > 25 Kg/mt2.
  • Visceral fat quantification > 9 (on a scale of 20).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese patients
Twenty obese patients treated by tecar therapy
Device: Tecar Therapy
Tecar Therapy at 1Mhz radiofrequency by the use of a C-400 device. The duration of the treatment will be 5 weeks, where 10 sessions will be carried out, 2 per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visceral Fat Loss (cm3)
Time Frame: 3 months
Measurement of Visceral fat loss (cm3) after Tecar Therapy treatment.
3 months
Visceral Fat Loss (g)
Time Frame: 3 months
Measurement of Visceral fat loss (g) after Tecar Therapy treatment.
3 months
Subcutaneous Fat Loss (cm3)
Time Frame: 3 months
Measurement of subcutaneous fat loss (cm3) after Tecar Therapy treatment.
3 months
Subcutaneous Fat Loss (g)
Time Frame: 3 months
Measurement of subcutaneous fat loss (g) after Tecar Therapy treatment.
3 months
Tumor Necrosis Factor Alfa
Time Frame: 3 months
Changes in serum/plasma levels of Tumor Necrosis Factor alfa (pg/mL) after Tecar Therapy treatment.
3 months
Interleukin 6 Levels
Time Frame: 3 months
Changes in serum/plasma levels of Interleukin 6 (pg/mL) after Tecar Therapy treatment.
3 months
C Reactive Protein Levels
Time Frame: 3 months
Changes in serum/plasma C reactive Protein (mg/L) after Tecar Therapy treatment.
3 months
Leptin Levels
Time Frame: 3 months
Changes in serum/plasma levels of leptin after Tecar Therapy treatment.
3 months
Adiponectin Levels
Time Frame: 3 months
Changes in serum/plasma levels of adiponectin after Tecar Therapy treatment.
3 months
Resistin Levels
Time Frame: 3 months
Changes in serum/plasma levels of resistin after Tecar Therapy treatment.
3 months
Total Cholesterol Changes
Time Frame: 3 months
Measurement of serum total cholesterol (mg/dL) after Tecar Therapy treatment.
3 months
Total Triglycerides Changes
Time Frame: 3 months
Measurement of serum total triglycerides (mg/dL) after Tecar Therapy treatment.
3 months
LDL Cholesterol Changes
Time Frame: 3 months
Measurement of serum LDL Cholesterol (mg/dL) after Tecar Therapy treatment.
3 months
HDL Cholesterol Changes
Time Frame: 3 months
Measurement of serum HDL Cholesterol (mg/dL) after Tecar Therapy treatment.
3 months
Glucose
Time Frame: 3 months
Measurement of Glucose (mg/dL) after Tecar Therapy treatment.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index Loss
Time Frame: 3 months
Measurement of Body Mass Index loss (Kg/m2) after Tecar Therapy treatment.
3 months
Waist to Hip Ratio (WHR-unitless) Loss
Time Frame: 3 months
Measurement of the WHR loss after the Tecar Therapy treatment. It is calculated by dividing waist circumference by hip circumference. It is a unitless measure indicating fat distribution, with lower values reflecting reduced abdominal fat.
3 months
Skinfold Thickness (mm)
Time Frame: 3 months
Measurement of the Skinfold Thickness (mm) after Tecar Therapy treatment.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CAPENERGY MEDICAL, SL

Collaborators

University of Malaga
Alfonso X El Sabio University

Investigators

  • Principal Investigator: Jesús Rodríguez Lastra, PhD, MD, Alfonso X El Sabio University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2022

Primary Completion (Actual)

July 25, 2022

Study Completion (Actual)

June 22, 2023

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEEAH CA31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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