Trial Outcomes & Findings for Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy. (NCT NCT06377358)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

3 months

Results posted on

2025-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Obese Patients Twenty obese patients treated by tecar therapy
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obese Patients n=20 Participants Twenty obese patients treated by tecar therapy 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
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants
Age, Continuous	49 years STANDARD_DEVIATION 11 • n=20 Participants
Sex: Female, Male Female	10 Participants n=20 Participants
Sex: Female, Male Male	10 Participants n=20 Participants
Region of Enrollment Spain	20 Participants n=20 Participants
Visceral adipose Tissue (VAT) in grams (g)	3988 grams STANDARD_DEVIATION 1850 • n=20 Participants
Subcutaneous Fat Tissue (SFT) in g	9124 grams STANDARD_DEVIATION 2804 • n=20 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Visceral Fat Loss (cm3)	-628 cm3 Standard Deviation 103

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Visceral Fat Loss (g)	-565 grams Standard Deviation 93

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by tecar therapy Tecar Therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Subcutaneous Fat Loss (cm3)	-803 cm3 Standard Deviation 492

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients were treated by TECAR therapy.

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Subcutaneous Fat Loss (g)	-845 grams Standard Deviation 433

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients were treated by TECAR therapy.

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Tumor Necrosis Factor Alfa	0.70 pg/mL Standard Deviation 2.5

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Interleukin 6 Levels	-0.53 pg/mL Standard Deviation 2.2

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
C Reactive Protein Levels	0.12 mg/L Standard Deviation 3.14

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Leptin Levels	-7.33 ng/mL Standard Deviation 7.28

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Adiponectin Levels	-296.9 ng/mL Standard Deviation 1023.8

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Resistin Levels	-0.19 ng/mL Standard Deviation 1.21

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Total Cholesterol Changes	-11.8 mg/dL Standard Deviation 16.8

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Total Triglycerides Changes	-15.6 mg/dL Standard Deviation 46

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
LDL Cholesterol Changes	-6.15 mg/dL Standard Deviation 21.6

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
HDL Cholesterol Changes	-2.6 mg/dL Standard Deviation 5.47

PRIMARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

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

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Glucose	-3.5 mg/dL Standard Deviation 6.83

SECONDARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

Measurement of Body Mass Index loss (Kg/m2) after Tecar Therapy treatment.

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Body Mass Index Loss	0 kg/m2 Standard Deviation 2

SECONDARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy.

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.

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Waist to Hip Ratio (WHR-unitless) Loss	-0.02 unitless Standard Deviation 0.05

SECONDARY outcome

Timeframe: 3 months

Population: Twenty obese patients treated by TECAR therapy

Measurement of the Skinfold Thickness (mm) after Tecar Therapy treatment.

Outcome measures

Outcome measures
Measure	20 Obese Patients n=20 Participants Twenty obese patients treated by TECAR therapy
Skinfold Thickness (mm)	-1.85 mm Standard Deviation 2.36

Adverse Events

Obese Patients

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Obese Patients n=20 participants at risk Twenty obese patients treated by tecar therapy
Skin and subcutaneous tissue disorders Erythema	20.0% 4/20 • Number of events 10 • 2 weeks No Serious Adverse Events or All-Cause Mortality occurred during the study

Additional Information

José Rioja Villodres

University of Malaga

Phone: (+34) 952 137 278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place