NCT03119350

Brief Summary

Considering that the failure of the treatment of obesity is justified by the multifactorial pathophysiology of this morbidity, the present project has the following hypotheses:

  1. 1.The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ;
  2. 2.The unbalance is therapeutically modified through physical training ;
  3. 3.Obesity courses with the break-down in energy metabolism mitochondrial disease associated with systemic inflammatory characteristics that can be corrected through a combined long-term physical training program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

April 10, 2017

Last Update Submit

April 27, 2019

Conditions

Outcome Measures

Primary Outcomes (13)

  • Changes Body weight

    Body weight was measured by digital balance before and after the intervention

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes Body composition

    The change in body composition through deuterium oxide was evaluated.

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes White adipose tissue biopsy

    A subcutaneous tissue sample was collected for analysis of: mitochondrial respiration, citrate synthase enzyme, gene expression (UCP1, 2 and 3).

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes Indirect calorimetry

    With a gas analyzer (indirect calorimeter), we evaluated the metabolic rate and rest (REE) and oxidation of substrates (Lipids and carbohydrates).

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes in fatty acids

    Collected in lithium heparin tubes, they were centrifuged.

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes oxidative stress

    Collected in lithium heparin tubes, they were centrifuged.

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes inflammatory cytokines

    Collected in lithium heparin tubes, they were centrifuged.

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes in total cholesterol

    Collected in lithium heparin tubes, they were centrifuged.

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes Physical Performance

    Based on the Shuttle Walking Test adaptation.

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes in Determination of Lactate

    Blood samples were collected by manual puncture of the earlobe in previously calibrated and heparinized capillary tubes, stored in eppendorf with sodium fluoride. Analyzed by electrochemical lactate analyser.

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes Food intake

    Food registry of 3 days, the quantification of the daily intake of nutrients will still be made using software.

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes Nitrogen Balance

    Through the collection of urine of 24 hours the dosage of urinary nitrogen will be made by the chemiluminescence method for determination of protein nitrogen.

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

  • Changes Telomere length

    peripheral blood in ethylenediaminetetraacetic acid tubes and genomic DNA was automatically extracted from Peripheral Blood Mononuclear Cell. The relative quantification of Telomere length was determined using the telomere to single copy gene ratio by Quantitative Polymerase Chain Reaction (qPCR).

    Two times: (1) First day and (2) 10 weeks after adaptation and intervention

Study Arms (1)

Physical Training

OTHER

There was concurrent physical training intervention: strength and aerobic exercises in the same session. Duration: 2 weeks of adaptation and learning to exercise, 8 weeks of physical training. Frequency: 3 times per week Duration: 55 minutes each session. Intensity: 75 to 90% of maximum heart rate.

Other: Physical Training

Interventions

Intervention with concurrent physical training: strength and aerobic exercises in the same session. Duration: 2 weeks of adaptation to physical exercise, 8 weeks of training. Frequency: 3 times a week. Time: 55 minutes each session. Intensity: 75 to 90% of maximum heart rate.

Physical Training

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • This study included women with obesity (BMI of 30 to 40 kg / m²), sedentary, with no associated comorbidity, convenience sample

You may not qualify if:

  • Women who have undergone bariatric surgery, menopause, cancer or any metabolic disease, smokers, alcoholics, who are in use of drugs that act directly on the metabolism and that have medical impediment to the practice of physical exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camila Fernanda Cunha Brandão

Ribeirão Preto, São Paulo, 14.048-900, Brazil

Location

Related Publications (28)

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    BACKGROUND
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    PMID: 18417645BACKGROUND
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    BACKGROUND
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    PMID: 27385544BACKGROUND
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    BACKGROUND
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    PMID: 9662690BACKGROUND
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    PMID: 6618956BACKGROUND
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    PMID: 3125351BACKGROUND
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    PMID: 17244782BACKGROUND
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    PMID: 17827403BACKGROUND
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    PMID: 27774458BACKGROUND
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    PMID: 20421291BACKGROUND
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    PMID: 6530596BACKGROUND
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    PMID: 11003256BACKGROUND
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    PMID: 20921196BACKGROUND
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    PMID: 22323345BACKGROUND
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    BACKGROUND
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MeSH Terms

Conditions

Metabolic DiseasesMotor ActivityObesity

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesBehaviorOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 18, 2017

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

September 15, 2016

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations