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New Therapeutic Perspectives in Obesity

Primary Purpose

Obesity;

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Phototherapy
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity; focused on measuring anthropometric parameters;, biochemical parameters;, inflammatory markers, neuropeptide markers, phototherapy

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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 .

Sites / Locations

  • Unversidade Federal de São Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Lifestyle counseling

Phototherapy

Arm Description

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: 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

Outcomes

Primary Outcome Measures

Anthropometric measure
Weight body: this measure would occurs during each week.
anthropometric parameter
total body fat: this measure would occurs during each week
anthropometric parameter
visceral body fat: this measure would occurs during each week
anthropometric parameter
total muscle

Secondary Outcome Measures

Primary biochemical analyzes
The primary biochemical: glicemic variables (glucose and insulin)
Primary biochemical analyzes
the lipids variables (total cholesterol; triglycerides; low density lipoprotein; very low density lipoprotein; high density lipoprotein)

Full Information

First Posted
April 28, 2014
Last Updated
May 27, 2014
Sponsor
Universidade Federal de Sao Carlos
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02153021
Brief Title
New Therapeutic Perspectives in Obesity
Official Title
New Therapeutic Perspectives in Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity;
Keywords
anthropometric parameters;, biochemical parameters;, inflammatory markers, neuropeptide markers, phototherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Phototherapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Phototherapy
Other Intervention Name(s)
laser, lasertherapy, low-level laser therapy
Intervention Description
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 Measure Information:
Title
Anthropometric measure
Description
Weight body: this measure would occurs during each week.
Time Frame
the measure occur up to 20 weeks
Title
anthropometric parameter
Description
total body fat: this measure would occurs during each week
Time Frame
the measure occur up to 20 weeks
Title
anthropometric parameter
Description
visceral body fat: this measure would occurs during each week
Time Frame
the measure occur up to 20 weeks
Title
anthropometric parameter
Description
total muscle
Time Frame
the measure occur up to 20 weeks
Secondary Outcome Measure Information:
Title
Primary biochemical analyzes
Description
The primary biochemical: glicemic variables (glucose and insulin)
Time Frame
the measures occur up to 20 weeks
Title
Primary biochemical analyzes
Description
the lipids variables (total cholesterol; triglycerides; low density lipoprotein; very low density lipoprotein; high density lipoprotein)
Time Frame
the measure occur up to 20 weeks
Other Pre-specified Outcome Measures:
Title
measure of neuropeptide
Description
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);
Time Frame
measures up to 20 weeks
Title
measure of interleukines and citokines
Description
interleukines and citokines variables: iL-1; iL-4; iL-6; iL-10; c reactive protein.
Time Frame
the measure occur up to 20 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nivaldo A Parizotto, PhD
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversidade Federal de São Carlos
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13565905
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio E de AquinoJunior, Master
Phone
+55XX16991721127
Email
antonioaquino@ursa.ifsc.usp.br
First Name & Middle Initial & Last Name & Degree
Antonio E de Aquino Junior, Master

12. IPD Sharing Statement

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New Therapeutic Perspectives in Obesity

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