Mitochondrial Energy Metabolism in Obese Women

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03119350

Collaborator

(none)

Enrollment

Location

Arm

5.5

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolism Disorder Mitochondrial Alteration Physical Activity Obesity	Other: Physical Training	N/A

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 Design

Study Type:

Interventional

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 :

Apr 1, 2016

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Sep 15, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes Body weight [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 [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 [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 [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 [Two times: (1) First day and (2) 10 weeks after adaptation and intervention]
Collected in lithium heparin tubes, they were centrifuged.
Changes oxidative stress [Two times: (1) First day and (2) 10 weeks after adaptation and intervention]
Collected in lithium heparin tubes, they were centrifuged.
Changes inflammatory cytokines [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 [Two times: (1) First day and (2) 10 weeks after adaptation and intervention]
Collected in lithium heparin tubes, they were centrifuged.
Changes Physical Performance [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 [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Camila Fernanda Cunha Brandão	Ribeirao Preto	SP	Brazil	14.048-900

Sponsors and Collaborators

University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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:

Apr 18, 2017

Last Update Posted:

Apr 30, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolic Diseases

Study Results

No Results Posted as of Apr 30, 2019