protocolSection identificationModule nctId: NCT06377358, orgStudyIdInfo id: CEEAH CA31, briefTitle: Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-09, primaryCompletionDateStruct date: 2022-07-25, completionDateStruct date: 2023-06-22, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: CAPENERGY MEDICAL, SL, class: INDUSTRY, collaborators name: University of Malaga, collaborators name: Alfonso X El Sabio University, descriptionModule briefSummary: 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., conditionsModule conditions: Obesity, Visceral, conditions: Obesity; Endocrine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Tecar Therapy, outcomesModule primaryOutcomes measure: Visceral fat loss (cm3), primaryOutcomes measure: Visceral fat loss (g), primaryOutcomes measure: Subcutaneous fat loss (cm3), primaryOutcomes measure: Subcutaneous fat loss (g), primaryOutcomes measure: Tumor Necrosis Factor alfa, primaryOutcomes measure: Interleukin 6 levels, primaryOutcomes measure: C reactive Protein levels, primaryOutcomes measure: Leptin levels, primaryOutcomes measure: Adiponectin levels, primaryOutcomes measure: Resistin levels, primaryOutcomes measure: Total cholesterol changes, primaryOutcomes measure: Total triglycerides changes, primaryOutcomes measure: LDL Cholesterol changes, primaryOutcomes measure: HDL Cholesterol changes, primaryOutcomes measure: Glucose, secondaryOutcomes measure: Body Mass Index loss, secondaryOutcomes measure: Waist to Hip Index loss, secondaryOutcomes measure: Skinfold Thickness (cm), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inneo Terapia Despi, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-02-01, uploadDate: 2024-03-21T05:39, filename: Prot_SAP_000.pdf, size: 597014, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-02-01, uploadDate: 2024-04-11T07:17, filename: ICF_001.pdf, size: 543945, hasResults: False