New Therapeutic Perspectives in Obesity

Universidade Federal de Sao Carlos

Status and phase: Unknown; Phase 1

Conditions: Obesity;

Treatments: Radiation: Phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02153021

231.286

Details and patient eligibility

About

Obesity is a chronic disease of increasing prevalence, being currently considered a global epidemic, including children, adolescents, adults and the elderly of different nationalities and ethnicities, socioeconomic levels, education levels. Non-pharmacological therapeutic interventions, such as physical exercise and fitness healthy eating strategies seem to be increasingly studied and recommended for healthy weight loss. In addition, therapies that can complement the effect of exercise and diet for reducing body weight are considerate important strategies. Thus, experimental evidence shows that the use of laser therapy combined with exercise swimming was effective in controlling the lipid profile, reducing the mass of adipose tissue, suggesting increased metabolic activity and changes in lipid metabolism.

To investigate the effect of the use of therapeutic laser when associated to exercise like response to new therapy for weight loss and decrease of dyslipidemias levels.

Full description

Methods:

During 20 weeks, each patients will receive 3 session of exercise with duration of 1 hour. Each session of exercise will composed of aerobic exercise and resistence exercise. After training session, each patient will receive application of phototherapy during 16 minutes. The protocol of phototherapy appplication is described in link "interventions"

Enrollment: 64 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• volunteers aged 20-40 years with a body mass index (BMI) ≥ 30 above, of both genders with primary obesity;

Exclusion criteria

• The criteria for inclusion are volunteers who use contraceptive use, cortisone, anti-epileptic drugs, history of kidney and heart disease, alcohol abuse, smoking, use of supplemental vitamins or secondary diagnosis of obesity.

After the pre-selection in the initial interview, the volunteers who contemplate all the inclusion criteria will be referred for clinical evaluation with an interdisciplinary health team and the electrocardiogram stress test to verify the release of the practice of physical exercises proposed by the project .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups, including a placebo group

Lifestyle counseling

Placebo Comparator group

Description:

alimentation information: a nutritionist provides nutritional orientation; exercise training: 3 days by week the patients will have specific sessions of resistance training (30 minutes) and aerobic training (30 minutes); phototherapy: all patients will received application of phototherapy after exercise session. The phototherapy will be applicated in abdominal and dorsal circumference/ quadriceps and biceps femoral. In Sham group,the equipment will be off.

Phototherapy

Active Comparator group

Description:

phototherapy: all patientes will received application of phototherapy after exercise session. The phototherapy will be applicated in abdominal and dorsal circumference/ quadriceps and biceps femoral. Type Ga-Al-As Wavelength 808nm Frenquency Continue wave Optical output 100mW Spot diameter 0.6mm Power density 60W/cm2 Energy per minute 6J/point Number of Points 64points Total energy delivered 48J

Treatment:

Radiation: Phototherapy