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Completed

NCT Number: NCT03119350

Mitochondrial Energy Metabolism in Obese Women

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.

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.

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Key information

Conditions

Metabolism Disorder Behavior Body Weight Metabolic Diseases Mitochondrial Alteration Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Camila Fernanda Cunha Brandão

Ribeirão Preto, São Paulo, 14.048-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical training

Other

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Mitochondrial Energy Metabolism in Obese Women Undergoing Concurrent Physical Training

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 18, 2017
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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