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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

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
      • 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

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
Intervention / Treatment
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

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

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

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Maysa Sousa, University of São 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

November 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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