Mitochondrial Energy Metabolism in Obese Women
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| ClinicalTrials.gov Identifier: NCT03119350 |
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Recruitment Status :
Completed
First Posted : April 18, 2017
Last Update Posted : April 30, 2019
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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:
- The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ;
- The unbalance is therapeutically modified through physical training ;
- 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.
This study have as objective : to analyse changes in mitochondrial function, inflammatory profile, oxidative stress and energy metabolism caused by concurrent physical training in obese women.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metabolism Disorder Mitochondrial Alteration Physical Activity Obesity | Other: Physical Training | Not Applicable |
Specific objectives:
Body composition by deuterium oxide; Metabolic rate of resting and oxidation of substrates by indirect calorimetry; Proinflammatory cytokines Anti-inflammatory cytokines Oxidative Stress: Malondialdehyde, Superoxide Dismutase, Glutathione-Peroxidase; Fatty acids: ceramide and palmitate; Mitochondrial respiration and citrate synthase enzyme; Quantify and qualify: mitochondrial number, endoplasmic reticulum structure, adipose cell size; Gene expression, quantify by microscopy and analyze the protein by western blot.
The study began with 20 women, however, there was withdrawal of 6, ending with 14 women.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Mitochondrial Energy Metabolism in Obese Women Undergoing Concurrent Physical Training |
| Actual Study Start Date : | April 1, 2016 |
| Actual Primary Completion Date : | July 1, 2016 |
| Actual Study Completion Date : | September 15, 2016 |
| Arm | Intervention/treatment |
|---|---|
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Physical Training
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
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. |
- Changes Body weight [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]Body weight was measured by digital balance before and after the intervention
- Changes Body composition [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]The change in body composition through deuterium oxide was evaluated.
- Changes White adipose tissue biopsy [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]A subcutaneous tissue sample was collected for analysis of: mitochondrial respiration, citrate synthase enzyme, gene expression (UCP1, 2 and 3).
- Changes Indirect calorimetry [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]With a gas analyzer (indirect calorimeter), we evaluated the metabolic rate and rest (REE) and oxidation of substrates (Lipids and carbohydrates).
- Changes in fatty acids [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]Collected in lithium heparin tubes, they were centrifuged.
- Changes oxidative stress [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]Collected in lithium heparin tubes, they were centrifuged.
- Changes inflammatory cytokines [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]Collected in lithium heparin tubes, they were centrifuged.
- Changes in total cholesterol [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]Collected in lithium heparin tubes, they were centrifuged.
- Changes Physical Performance [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]Based on the Shuttle Walking Test adaptation.
- Changes in Determination of Lactate [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]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.
- Changes Food intake [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]Food registry of 3 days, the quantification of the daily intake of nutrients will still be made using software.
- Changes Nitrogen Balance [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]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.
- Changes Telomere length [ Time Frame: Two times: (1) First day and (2) 10 weeks after adaptation and intervention ]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).
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| Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- This study included women with obesity (BMI of 30 to 40 kg / m²), sedentary, with no associated comorbidity, convenience sample
Exclusion Criteria:
- 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.
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): NCT03119350
| Brazil | |
| Camila Fernanda Cunha Brandão | |
| Ribeirao Preto, SP, Brazil, 14.048-900 | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Julio Sergio Marchini, Principal Investigator, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT03119350 |
| Other Study ID Numbers: |
Process HCRP: 1.387.040/2016 |
| First Posted: | April 18, 2017 Key Record Dates |
| Last Update Posted: | April 30, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Metabolic Diseases |