Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy.

NCT06377358 | Completed Results

• 1 other identifier: CEEAH CA31
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Visceral; Obesity; Endocrine

Keywords

Tecar Therapy; Fat; Inflammation; Adipokines

Outcome Measures

Primary Outcomes (15)

• Visceral Fat Loss (cm3)

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

  3 months

• Visceral Fat Loss (g)

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

  3 months

• Subcutaneous Fat Loss (cm3)

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

  3 months

• Subcutaneous Fat Loss (g)

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

  3 months

• Tumor Necrosis Factor Alfa

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

  3 months

• Interleukin 6 Levels

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

  3 months

• C Reactive Protein Levels

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

  3 months

• Leptin Levels

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

  3 months

• Adiponectin Levels

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

  3 months

• Resistin Levels

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

  3 months

• Total Cholesterol Changes

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

  3 months

• Total Triglycerides Changes

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

  3 months

• LDL Cholesterol Changes

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

  3 months

• HDL Cholesterol Changes

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

  3 months

• Glucose

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

  3 months

Secondary Outcomes (3)

• Body Mass Index Loss

  3 months

• Waist to Hip Ratio (WHR-unitless) Loss

  3 months

• Skinfold Thickness (mm)

  3 months

Study Arms (1)

Obese patients

EXPERIMENTAL

Twenty obese patients treated by tecar therapy

Device: Tecar Therapy

Interventions

Tecar Therapy DEVICE

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

Obese patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAPENERGY MEDICAL, SL: lead
• University of Malaga: collaborator
• Alfonso X El Sabio University: collaborator

Study Sites (1)

Inneo Terapia Despi

Barcelona, Spain

Location

Related Publications (36)

• Araki E, Oyadomari S, Mori M. Impact of endoplasmic reticulum stress pathway on pancreatic beta-cells and diabetes mellitus. Exp Biol Med (Maywood). 2003 Nov;228(10):1213-7. doi: 10.1177/153537020322801018.

  PMID: 14610263 BACKGROUND

• Badawi A, Klip A, Haddad P, Cole DE, Bailo BG, El-Sohemy A, Karmali M. Type 2 diabetes mellitus and inflammation: Prospects for biomarkers of risk and nutritional intervention. Diabetes Metab Syndr Obes. 2010 May 26;3:173-86. doi: 10.2147/dmsott.s9089.

  PMID: 21437087 BACKGROUND

• Belenky I, Margulis A, Elman M, Bar-Yosef U, Paun SD. Exploring channeling optimized radiofrequency energy: a review of radiofrequency history and applications in esthetic fields. Adv Ther. 2012 Mar;29(3):249-66. doi: 10.1007/s12325-012-0004-1. Epub 2012 Feb 29.

  PMID: 22382873 BACKGROUND

• Bjorntorp P. "Portal" adipose tissue as a generator of risk factors for cardiovascular disease and diabetes. Arteriosclerosis. 1990 Jul-Aug;10(4):493-6. No abstract available.

  PMID: 2196039 BACKGROUND

• Chang SL, Huang YL, Lee MC, Chang CH, Lin YF, Cheng CY, Hu S. Long-term follow-up for noninvasive body contouring treatment in Asians. Lasers Med Sci. 2016 Feb;31(2):283-7. doi: 10.1007/s10103-015-1852-0. Epub 2015 Dec 29.

  PMID: 26714982 BACKGROUND

• Duarte FO, Sene-Fiorese M, de Aquino Junior AE, da Silveira Campos RM, Masquio DC, Tock L, Garcia de Oliveira Duarte AC, Damaso AR, Bagnato VS, Parizotto NA. Can low-level laser therapy (LLLT) associated with an aerobic plus resistance training change the cardiometabolic risk in obese women? A placebo-controlled clinical trial. J Photochem Photobiol B. 2015 Dec;153:103-10. doi: 10.1016/j.jphotobiol.2015.08.026. Epub 2015 Sep 2.

  PMID: 26398817 BACKGROUND

• Ellulu MS, Patimah I, Khaza'ai H, Rahmat A, Abed Y. Obesity and inflammation: the linking mechanism and the complications. Arch Med Sci. 2017 Jun;13(4):851-863. doi: 10.5114/aoms.2016.58928. Epub 2016 Mar 31.

  PMID: 28721154 BACKGROUND

• Alexiades-Armenakas M, Dover JS, Arndt KA. Unipolar radiofrequency treatment to improve the appearance of cellulite. J Cosmet Laser Ther. 2008 Sep;10(3):148-53. doi: 10.1080/14764170802279651.

  PMID: 18788033 BACKGROUND

• Eloi JC, Epifanio M, de Goncalves MM, Pellicioli A, Vieira PF, Dias HB, Bruscato N, Soder RB, Santana JC, Mouzaki M, Baldisserotto M. Quantification of Abdominal Fat in Obese and Healthy Adolescents Using 3 Tesla Magnetic Resonance Imaging and Free Software for Image Analysis. PLoS One. 2017 Jan 27;12(1):e0167625. doi: 10.1371/journal.pone.0167625. eCollection 2017.

  PMID: 28129354 BACKGROUND

• Fritz K, Salavastru C, Gyurova M. Clinical evaluation of simultaneously applied monopolar radiofrequency and targeted pressure energy as a new method for noninvasive treatment of cellulite in postpubertal women. J Cosmet Dermatol. 2018 Jun;17(3):361-364. doi: 10.1111/jocd.12525. Epub 2018 Mar 9.

  PMID: 29524305 BACKGROUND

• Gabai VL, Meriin AB, Yaglom JA, Wei JY, Mosser DD, Sherman MY. Suppression of stress kinase JNK is involved in HSP72-mediated protection of myogenic cells from transient energy deprivation. HSP72 alleviates the stewss-induced inhibition of JNK dephosphorylation. J Biol Chem. 2000 Dec 1;275(48):38088-94. doi: 10.1074/jbc.M006632200.

  PMID: 10978340 BACKGROUND

• Janssen I, Heymsfield SB, Allison DB, Kotler DP, Ross R. Body mass index and waist circumference independently contribute to the prediction of nonabdominal, abdominal subcutaneous, and visceral fat. Am J Clin Nutr. 2002 Apr;75(4):683-8. doi: 10.1093/ajcn/75.4.683.

  PMID: 11916754 BACKGROUND

• Janssen I, Katzmarzyk PT, Ross R. Waist circumference and not body mass index explains obesity-related health risk. Am J Clin Nutr. 2004 Mar;79(3):379-84. doi: 10.1093/ajcn/79.3.379.

  PMID: 14985210 BACKGROUND

• Kaplan H, Gat A. Clinical and histopathological results following TriPollar radiofrequency skin treatments. J Cosmet Laser Ther. 2009 Jun;11(2):78-84. doi: 10.1080/14764170902846227.

  PMID: 19408182 BACKGROUND

• Klopfenstein BJ, Kim MS, Krisky CM, Szumowski J, Rooney WD, Purnell JQ. Comparison of 3 T MRI and CT for the measurement of visceral and subcutaneous adipose tissue in humans. Br J Radiol. 2012 Oct;85(1018):e826-30. doi: 10.1259/bjr/57987644. Epub 2012 Apr 18.

  PMID: 22514099 BACKGROUND

• Kondo T, Sasaki K, Matsuyama R, Morino-Koga S, Adachi H, Suico MA, Kawashima J, Motoshima H, Furukawa N, Kai H, Araki E. Hyperthermia with mild electrical stimulation protects pancreatic beta-cells from cell stresses and apoptosis. Diabetes. 2012 Apr;61(4):838-47. doi: 10.2337/db11-1098. Epub 2012 Feb 23.

  PMID: 22362176 BACKGROUND

• Maffeis C, Corciulo N, Livieri C, Rabbone I, Trifiro G, Falorni A, Guerraggio L, Peverelli P, Cuccarolo G, Bergamaschi G, Di Pietro M, Grezzani A. Waist circumference as a predictor of cardiovascular and metabolic risk factors in obese girls. Eur J Clin Nutr. 2003 Apr;57(4):566-72. doi: 10.1038/sj.ejcn.1601573.

  PMID: 12700618 BACKGROUND

• Mazzoni D, Lin MJ, Dubin DP, Khorasani H. Review of non-invasive body contouring devices for fat reduction, skin tightening and muscle definition. Australas J Dermatol. 2019 Nov;60(4):278-283. doi: 10.1111/ajd.13090. Epub 2019 Jun 6.

  PMID: 31168833 BACKGROUND

• Minami Y, Hohfeld J, Ohtsuka K, Hartl FU. Regulation of the heat-shock protein 70 reaction cycle by the mammalian DnaJ homolog, Hsp40. J Biol Chem. 1996 Aug 9;271(32):19617-24. doi: 10.1074/jbc.271.32.19617.

  PMID: 8702658 BACKGROUND

• Moreno LA, Pineda I, Rodriguez G, Fleta J, Sarria A, Bueno M. Waist circumference for the screening of the metabolic syndrome in children. Acta Paediatr. 2002;91(12):1307-12. doi: 10.1080/08035250216112.

  PMID: 12578286 BACKGROUND

• Morino S, Suico MA, Kondo T, Sekimoto E, Yano S, Matsuda T, Matsuno T, Shuto T, Araki E, Kai H. Mild electrical stimulation increases ubiquitinated proteins and Hsp72 in A549 cells via attenuation of proteasomal degradation. J Pharmacol Sci. 2008 Oct;108(2):222-6. doi: 10.1254/jphs.08180sc. Epub 2008 Oct 10.

  PMID: 18845908 BACKGROUND

• Mulholland RS, Paul MD, Chalfoun C. Noninvasive body contouring with radiofrequency, ultrasound, cryolipolysis, and low-level laser therapy. Clin Plast Surg. 2011 Jul;38(3):503-20, vii-iii. doi: 10.1016/j.cps.2011.05.002.

  PMID: 21824546 BACKGROUND

• Ohlson LO, Larsson B, Svardsudd K, Welin L, Eriksson H, Wilhelmsen L, Bjorntorp P, Tibblin G. The influence of body fat distribution on the incidence of diabetes mellitus. 13.5 years of follow-up of the participants in the study of men born in 1913. Diabetes. 1985 Oct;34(10):1055-8. doi: 10.2337/diab.34.10.1055.

  PMID: 4043554 BACKGROUND

• Park HS, Lee JS, Huh SH, Seo JS, Choi EJ. Hsp72 functions as a natural inhibitory protein of c-Jun N-terminal kinase. EMBO J. 2001 Feb 1;20(3):446-56. doi: 10.1093/emboj/20.3.446.

  PMID: 11157751 BACKGROUND

• Pereira JX, Cavalcante Y, Wanzeler de Oliveira R. The role of inflammation in adipocytolytic nonsurgical esthetic procedures for body contouring. Clin Cosmet Investig Dermatol. 2017 Feb 23;10:57-66. doi: 10.2147/CCID.S125580. eCollection 2017.

  PMID: 28260937 BACKGROUND

• Pinto H. Local fat treatments: classification proposal. Adipocyte. 2015 Jun 26;5(1):22-6. doi: 10.1080/21623945.2015.1066534. eCollection 2016 Jan-Mar.

  PMID: 27144093 BACKGROUND

• Pumprla J, Howorka K, Kolackova Z, Sovova E. Non-contact radiofrequency-induced reduction of subcutaneous abdominal fat correlates with initial cardiovascular autonomic balance and fat tissue hormones: safety analysis. F1000Res. 2015 Feb 20;4:49. doi: 10.12688/f1000research.5708.1. eCollection 2015.

  PMID: 26069728 BACKGROUND

• Rexrode KM, Carey VJ, Hennekens CH, Walters EE, Colditz GA, Stampfer MJ, Willett WC, Manson JE. Abdominal adiposity and coronary heart disease in women. JAMA. 1998 Dec 2;280(21):1843-8. doi: 10.1001/jama.280.21.1843.

  PMID: 9846779 BACKGROUND

• Ryden M, Arner P. Subcutaneous Adipocyte Lipolysis Contributes to Circulating Lipid Levels. Arterioscler Thromb Vasc Biol. 2017 Sep;37(9):1782-1787. doi: 10.1161/ATVBAHA.117.309759. Epub 2017 Jun 29.

  PMID: 28663255 BACKGROUND

• Sharp FR, Massa SM, Swanson RA. Heat-shock protein protection. Trends Neurosci. 1999 Mar;22(3):97-9. doi: 10.1016/s0166-2236(98)01392-7. No abstract available.

  PMID: 10199631 BACKGROUND

• Shinohara T, Takahashi N, Ooie T, Hara M, Shigematsu S, Nakagawa M, Yonemochi H, Saikawa T, Yoshimatsu H. Phosphatidylinositol 3-kinase-dependent activation of akt, an essential signal for hyperthermia-induced heat-shock protein 72, is attenuated in streptozotocin-induced diabetic heart. Diabetes. 2006 May;55(5):1307-15. doi: 10.2337/db05-0266.

  PMID: 16644687 BACKGROUND

• Sugawara J, Kou S, Kokubo K, Kuroda A, Hashizume Y, Kobayashi S, Maegawa J, Satake T. Application for lower facial fat reduction and tightening by static type monopolar 1-MHz radio frequency for body contouring. Lasers Surg Med. 2017 Oct;49(8):750-755. doi: 10.1002/lsm.22676. Epub 2017 Apr 22.

  PMID: 28432775 BACKGROUND

• van der Lugt C, Romero C, Ancona D, Al-Zarouni M, Perera J, Trelles MA. A multicenter study of cellulite treatment with a variable emission radio frequency system. Dermatol Ther. 2009 Jan-Feb;22(1):74-84. doi: 10.1111/j.1529-8019.2008.01218.x.

  PMID: 19222519 BACKGROUND

• World Health Organization. Waist circumference and waist-hip ratio - Report of a WHO expert consultation, Geneva, 8-11 December 2008

  BACKGROUND

• Wu B, Hunt C, Morimoto R. Structure and expression of the human gene encoding major heat shock protein HSP70. Mol Cell Biol. 1985 Feb;5(2):330-41. doi: 10.1128/mcb.5.2.330-341.1985.

  PMID: 2858050 BACKGROUND

• Rodriguez Lastra J, Kouser S. Reduction of Subcutaneous and Visceral Fat With the Use of Energy-Based Equipment With a High-Power Amplifying Effect Plus an Exercise Regimen. J Cosmet Dermatol. 2025 Oct;24(10):e70490. doi: 10.1111/jocd.70490.

  PMID: 41059542 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal; Obesity; Platelet Glycoprotein IV Deficiency; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Limitations and Caveats

The limited sample size of this study, with only 20 participants recruited, represents a key limitation. Additionally, financial constraints posed a challenge, as covering the costs of MRI scans and blood analyses for a larger sample was not feasible

Results Point of Contact

• Title: José Rioja Villodres
• Organization: University of Malaga

jose.rioja@uma.es

(+34) 952 137 278

Study Officials

• Jesús Rodríguez Lastra, PhD, MD

  Alfonso X El Sabio University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Tecar Theraty was applied to 20 obese patients in order to assess the effect on the body fat loss, serum adipocytokines and imflammation. It was an interventional study in one group of patients. No controls. No masking.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: April 22, 2024
• Study Start: May 9, 2022
• Primary Completion: July 25, 2022
• Study Completion: June 22, 2023
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)