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Mitochondrial Energy Metabolism in Obese Women

Primary Purpose

Metabolism Disorder, Mitochondrial Alteration, Physical Activity

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Physical Training

About this trial

This is an interventional treatment trial for Metabolism Disorder

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Camila Fernanda Cunha Brandão

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Physical Training

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes Body weight

Body weight was measured by digital balance before and after the intervention

Changes Body composition

The change in body composition through deuterium oxide was evaluated.

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).

Changes Indirect calorimetry

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

Collected in lithium heparin tubes, they were centrifuged.

Changes oxidative stress

Collected in lithium heparin tubes, they were centrifuged.

Changes inflammatory cytokines

Collected in lithium heparin tubes, they were centrifuged.

Changes in total cholesterol

Collected in lithium heparin tubes, they were centrifuged.

Changes Physical Performance

Based on the Shuttle Walking Test adaptation.

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.

Changes Food intake

Food registry of 3 days, the quantification of the daily intake of nutrients will still be made using software.

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.

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03119350

First Posted

April 10, 2017

Last Updated

April 27, 2019

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT03119350

Brief Title

Mitochondrial Energy Metabolism in Obese Women

Official Title

Mitochondrial Energy Metabolism in Obese Women Undergoing Concurrent Physical Training

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

April 1, 2016 (Actual)

Primary Completion Date

July 1, 2016 (Actual)

Study Completion Date

September 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolism Disorder, Mitochondrial Alteration, Physical Activity, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physical Training

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Physical Training

Intervention Description

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 Outcome Measure Information:

Title

Changes Body weight

Description

Body weight was measured by digital balance before and after the intervention

Time Frame