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New Therapeutic Perspectives in Obesity

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ClinicalTrials.gov Identifier: NCT02153021
Recruitment Status : Unknown
Verified May 2014 by Nivaldo Antonio Parizotto, Universidade Federal de Sao Carlos.
Recruitment status was:  Not yet recruiting
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Nivaldo Antonio Parizotto, 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.


Condition or disease Intervention/treatment Phase
Obesity; Radiation: Phototherapy Phase 1

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"


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: New Therapeutic Perspectives in Obesity
Study Start Date : September 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : February 2015

Arm Intervention/treatment
Placebo Comparator: Lifestyle counseling
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.
Active Comparator: 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

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

Other Names:
  • laser
  • lasertherapy
  • low-level laser therapy




Primary Outcome Measures :
  1. Anthropometric measure [ Time Frame: the measure occur up to 20 weeks ]
    Weight body: this measure would occurs during each week.

  2. anthropometric parameter [ Time Frame: the measure occur up to 20 weeks ]
    total body fat: this measure would occurs during each week

  3. anthropometric parameter [ Time Frame: the measure occur up to 20 weeks ]
    visceral body fat: this measure would occurs during each week

  4. anthropometric parameter [ Time Frame: the measure occur up to 20 weeks ]
    total muscle


Secondary Outcome Measures :
  1. Primary biochemical analyzes [ Time Frame: the measures occur up to 20 weeks ]
    The primary biochemical: glicemic variables (glucose and insulin)

  2. Primary biochemical analyzes [ Time Frame: the measure occur up to 20 weeks ]
    the lipids variables (total cholesterol; triglycerides; low density lipoprotein; very low density lipoprotein; high density lipoprotein)


Other Outcome Measures:
  1. measure of neuropeptide [ Time Frame: measures up to 20 weeks ]
    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);

  2. measure of interleukines and citokines [ Time Frame: the measure occur up to 20 weeks ]
    interleukines and citokines variables: iL-1; iL-4; iL-6; iL-10; c reactive protein.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 .


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153021


Locations
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Brazil
Unversidade Federal de São Carlos Not yet recruiting
São Carlos, São Paulo, Brazil, 13565905
Contact: Antonio E de AquinoJunior, Master    +55XX16991721127    antonioaquino@ursa.ifsc.usp.br   
Sub-Investigator: Antonio E de Aquino Junior, Master         
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Nivaldo A Parizotto, PhD Universidade Federal de Sao Carlos

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Responsible Party: Nivaldo Antonio Parizotto, PhD, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT02153021     History of Changes
Other Study ID Numbers: 231.286
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Keywords provided by Nivaldo Antonio Parizotto, Universidade Federal de Sao Carlos:
anthropometric parameters;
biochemical parameters;
inflammatory markers
neuropeptide markers
phototherapy
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms