Soccer and Health: Diet and Exercise on Type 2 Diabetes Mellitus

September 22, 2015 updated by: University of Sao Paulo General Hospital

Soccer and Health: Impact of Nutritional Intervention and Recreational Soccer Training in Patients With Type 2 Diabetes Mellitus

The present study aims to evaluate the impact of a soccer training program lasting 12 weeks in patients with type 2 diabetes mellitus. 60 sedentary adults and elderly patients with type 2 diabetes mellitus (age: 50-75 y), with a BMI > 25kg/m2 and > 29kg/m2, respectively, from the Hospital of the Medical Faculty of São Paulo University will participate in this study. They will be randomly divided in 3 groups (soccer, running and control). All patients will undergo the following assessments: anthropometric, dietary, physical performance, inflammatory, metabolic and hormonal parameters such as gene expression, bone markers and predictors of cardiovascular disease. In addition the investigators aim to evaluate the body composition of these patients by DXA, and muscle and visceral lipids content by proton spectroscopic MRI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The present study aims to evaluate the regular soccer practice on cardiorespiratory fitness, body composition, bone health and metabolic and hormonal variables, and compare it with other types of classic aerobic training, such as running, for example .

Soccer is a high popularity team sport, with more than 400 million active practitioners in the world, and due to various motivational and social factors of this activity we can consider it as a great tool potential in promoting the health of sedentary individuals, but football fans. Thus, we believe that the combined use of exercises that make up the soccer training, such as running, walking, sprints, acceleration, deceleration, jumps, side court, dribbling, etc., can result in significant adaptive changes in the physiological system, contributing improvements in cardiovascular function, bone mineralization in muscle strength, physical performance and metabolism of lipids and glucose.

Therefore we aimed to investigate in patients with diabetes mellitus type 2 the impact of a soccer training program with 12 weeks:

  • body composition, by examining DXA, assessing the content of lean mass and fat mass;
  • the concentration of muscle and visceral fat by means of nuclear magnetic resonance spectroscopy;
  • the bone markers for the quantification of osteocalcin hormone, carboxy terminal telopeptides (CTX), propeptide amino-terminal of procollagen type I (P1NP), parathyroid hormone (PTH) and 25-hydroxy vitamin D, growth factor insulin-like-1 free ( IGF1-free);

As a secondary objective, we intend to evaluate the impact of soccer training and classic aerobic exercise on metabolic and hormonal variables of type 2 diabetic patients:

  • the parameters of cardiovascular disease, for investigating blood pressure and quantification of lipid fractions (total cholesterol and fractions, triglycerides) and C-reactive protein;
  • physical performance, evaluating the physical capacity by examining ergospirometry;
  • and the metabolic variables, enzymatic and hormonal following: blood glucose, glycated hemoglobin (HbA1c), tolerance test oral glucose (OGTT), blood lactate, free fatty acids, blood count, insulin, proinsulin, leptin, adiponectin, and enzymes AST, ALT, CK and DHL.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • São Paulo, Brazil, 01246-903
        • Laboratory of Medical Investigation - LIM 18, University of São Paulo

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: patients with diabetes type 2 diabetes, up to 15 years in duration, HbA1c from 6.5 to 11.0%, with none administration of insulin.

Exclusion Criteria: patients with BMI lower (<) than 25 kg/m2 and higher (>) than 48 kg/m2, blood pressure > 160/100 mm Hg, fasting triglyceride levels of> 500 mg / dL, proteinuria> 100 mg / dL, serum creatinine> 1.5 mg / dL, liver complications, neuropathy or advanced retinopathy, macroangiopathy, diabetic foot, or any other serious health condition that impairs their adherence to the training protocol satisfactorily.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diet & Soccer

Nutritional Intervention (Diet) once a week, during 12 weeks

+ Soccer training, 3 times a week, during 12 weeks
Other: Diet
Nutrition intervention, once a week during 12 weeks
Other: Soccer
Nutrition intervention, once a week during 12 weeks + Soccer training, 3 x week, during 12 weeks
Experimental: Diet & Running

Nutritional Intervention (Diet) once a week, during 12 weeks

+ Running training, 3 times a week, during 12 weeks
Other: Diet
Nutrition intervention, once a week during 12 weeks
Other: Running
Nutrition intervention, once a week during 12 weeks + Running training, 3 x week, during 12 weeks
Active Comparator: Diet
Nutritional Intervention (Diet) once a week, during 12 weeks
Other: Soccer
Nutrition intervention, once a week during 12 weeks + Soccer training, 3 x week, during 12 weeks
Other: Running
Nutrition intervention, once a week during 12 weeks + Running training, 3 x week, during 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Attenuation of expression of proinflammatory genes verified by qPCR-array technique ranging from at least 5% in pre and post-intervention measurements
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Enhance physical performance verified by oxygen consumption measurement on treadmill
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maysa Sousa, University of Sao Paulo

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Exercise on Type 2 Diabetes

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.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings