Mitochondrial Energy Metabolism in Obese Women
1 other identifier
interventional
14
1 country
1
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.The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ;
- 2.The unbalance is therapeutically modified through physical training ;
- 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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2016
CompletedFirst Submitted
Initial submission to the registry
April 10, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedApril 30, 2019
April 1, 2019
3 months
April 10, 2017
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
OTHERThere 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.
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.
Eligibility Criteria
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
Related Publications (28)
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PMID: 31950310DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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