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Mitochondrial Energy Metabolism in Obese Women

27 de abril de 2019 actualizado por: Julio Sergio Marchini, University of Sao Paulo

Mitochondrial Energy Metabolism in Obese Women Undergoing Concurrent Physical Training

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

14

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Brasil
    • SP
      • Ribeirao Preto, SP, Brasil, 14.048-900
        • Camila Fernanda Cunha Brandão

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 40 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: 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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes Body weight
Periodo de tiempo: 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
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Body composition
Periodo de tiempo: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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
Periodo de tiempo: 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).
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Indirect calorimetry
Periodo de tiempo: 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).
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes in fatty acids
Periodo de tiempo: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Collected in lithium heparin tubes, they were centrifuged.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes oxidative stress
Periodo de tiempo: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Collected in lithium heparin tubes, they were centrifuged.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes inflammatory cytokines
Periodo de tiempo: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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
Periodo de tiempo: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Collected in lithium heparin tubes, they were centrifuged.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Physical Performance
Periodo de tiempo: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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
Periodo de tiempo: 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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Food intake
Periodo de tiempo: 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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Nitrogen Balance
Periodo de tiempo: 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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
Changes Telomere length
Periodo de tiempo: 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).
Two times: (1) First day and (2) 10 weeks after adaptation and intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Sao Paulo

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de abril de 2016

Finalización primaria (Actual)

1 de julio de 2016

Finalización del estudio (Actual)

15 de septiembre de 2016

Fechas de registro del estudio

Enviado por primera vez

10 de abril de 2017

Primero enviado que cumplió con los criterios de control de calidad

13 de abril de 2017

Publicado por primera vez (Actual)

18 de abril de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de abril de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

27 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Process HCRP: 1.387.040/2016

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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