Mitochondrial Energy Metabolism in Obese Women

April 27, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two times: (1) First day and (2) 10 weeks after adaptation and 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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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).
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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).
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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.
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
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).
Two times: (1) First day and (2) 10 weeks after adaptation and intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 15, 2016

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 27, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Process HCRP: 1.387.040/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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