Clinical trial NCT02153021: New Therapeutic Perspectives in Obesity
Official title: New Therapeutic Perspectives in Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Obesity;
Keywords: anthropometric parameters;
biochemical parameters;
inflammatory markers
neuropeptide markers
phototherapy
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-06-02
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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"

Eligibility criteria: 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 .

Primary outcomes:
measure: Anthropometric measure
timeFrame: the measure occur up to 20 weeks
measure: anthropometric parameter
timeFrame: the measure occur up to 20 weeks
measure: anthropometric parameter
timeFrame: the measure occur up to 20 weeks
measure: anthropometric parameter
timeFrame: the measure occur up to 20 weeks
Secondary outcomes:
measure: Primary biochemical analyzes
timeFrame: the measures occur up to 20 weeks
measure: Primary biochemical analyzes
timeFrame: the measure occur up to 20 weeks
Other outcomes:
measure: measure of neuropeptide
timeFrame: measures up to 20 weeks
measure: measure of interleukines and citokines
timeFrame: the measure occur up to 20 weeks
Locations:
city: São Carlos
country: Brazil
facility: Unversidade Federal de São Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Nivaldo A Parizotto, PhD
role: PRINCIPAL_INVESTIGATOR
References: