New Therapeutic Perspectives in Obesity

Phase 1

• Conditions: Obesity;
• Interventions: Radiation: Phototherapy

• Registration Number: NCT02153021
• Lead Sponsor: Universidade Federal de Sao Carlos

Brief Summary

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.

Detailed 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"

Study Timeline

• Study First Submitted: 2014-04-28
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-27
• Last Update Submitted: 2014-05-27
• Study First Posted: 2014-06-02
• Last Update Posted: 2014-06-02
• Study Start: 2014-09
• Primary Completion: 2014-12
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 64

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phototherapy	Phototherapy	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

Primary Outcome Measures

Name	Time	Method
Anthropometric measure	the measure occur up to 20 weeks	Weight body: this measure would occurs during each week.
anthropometric parameter	the measure occur up to 20 weeks	total muscle

Secondary Outcome Measures

Name	Time	Method
Primary biochemical analyzes	the measure occur up to 20 weeks	the lipids variables (total cholesterol; triglycerides; low density lipoprotein; very low density lipoprotein; high density lipoprotein)

Trial Locations

Locations (1)

Unversidade Federal de São Carlos; 🇧🇷 São Carlos, São Paulo, Brazil