New Therapeutic Perspectives in Obesity

NCT02153021 | Unknown Phase 1 DMC

• 1 other identifier: 231.286
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity;

Keywords

anthropometric parameters;; biochemical parameters;; inflammatory markers; neuropeptide markers; phototherapy

Outcome Measures

Primary Outcomes (4)

• Anthropometric measure

  Weight body: this measure would occurs during each week.

  the measure occur up to 20 weeks

• anthropometric parameter

  total body fat: this measure would occurs during each week

  the measure occur up to 20 weeks

• anthropometric parameter

  visceral body fat: this measure would occurs during each week

  the measure occur up to 20 weeks

• anthropometric parameter

  total muscle

  the measure occur up to 20 weeks

Secondary Outcomes (2)

• Primary biochemical analyzes

  the measures occur up to 20 weeks

• Primary biochemical analyzes

  the measure occur up to 20 weeks

Other Outcomes (2)

• measure of neuropeptide

  measures up to 20 weeks

• measure of interleukines and citokines

  the measure occur up to 20 weeks

Study Arms (2)

Lifestyle counseling

PLACEBO COMPARATOR

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

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

Radiation: Phototherapy

Interventions

Phototherapy RADIATION

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

Also known as: laser, lasertherapy, low-level laser therapy

Phototherapy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Unversidade Federal de São Carlos

São Carlos, São Paulo, 13565905, Brazil

Location

MeSH Terms

Conditions

Obesity

Interventions

Phototherapy; Lasers; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Laser Therapy

Study Officials

• Nivaldo A Parizotto, PhD

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: June 2, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

BR (1)