New Therapeutic Perspectives in Obesity

Obesity; Clinical Trial

Official title:

New Therapeutic Perspectives in Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02153021
• Other study ID #: 231.286
• Status: Not yet recruiting
• Phase: Phase 1
• First received: April 28, 2014
• Last updated: May 27, 2014
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2014
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Obesity;

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Brazil	Unversidade Federal de São Carlos	São Carlos	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	measure of neuropeptide	neuropeptides variables: neuropeptide Y (NPY); agouti-related peptide (agRP); melanotropic hormone (MCH); Leptine; alpha melanocyte stimulating (alpha MSH); Pro-opiomelanocortin (POMC); Cocaine-Amphetamine-Regulated Transcript (CART);	measures up to 20 weeks	Yes
Other	measure of interleukines and citokines	interleukines and citokines variables: iL-1; iL-4; iL-6; iL-10; c reactive protein.	the measure occur up to 20 weeks	Yes
Primary	Anthropometric measure	Weight body: this measure would occurs during each week.	the measure occur up to 20 weeks	Yes
Primary	anthropometric parameter	total body fat: this measure would occurs during each week	the measure occur up to 20 weeks	Yes
Primary	anthropometric parameter	visceral body fat: this measure would occurs during each week	the measure occur up to 20 weeks	Yes
Primary	anthropometric parameter	total muscle	the measure occur up to 20 weeks	Yes
Secondary	Primary biochemical analyzes	The primary biochemical: glicemic variables (glucose and insulin)	the measures occur up to 20 weeks	Yes
Secondary	Primary biochemical analyzes	the lipids variables (total cholesterol; triglycerides; low density lipoprotein; very low density lipoprotein; high density lipoprotein)	the measure occur up to 20 weeks	Yes