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Clinical Trials/NCT02554643
NCT02554643CompletedNot Applicable

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

University of Sao Paulo General Hospital1 site in 1 country60 target enrollmentStarted: November 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Attenuation of expression of proinflammatory genes verified by qPCR-array technique ranging from at least 5% in pre and post-intervention measurements

Study Overview

Brief Summary

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.

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Diet & Running

Experimental

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

  • Running training, 3 times a week, during 12 weeks

Intervention: Running (Other)

Diet & Soccer

Experimental

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

  • Soccer training, 3 times a week, during 12 weeks

Intervention: Diet (Other)

Diet & Soccer

Experimental

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

  • Soccer training, 3 times a week, during 12 weeks

Intervention: Soccer (Other)

Diet & Running

Experimental

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

  • Running training, 3 times a week, during 12 weeks

Intervention: Diet (Other)

Diet

Active Comparator

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

Intervention: Soccer (Other)

Diet

Active Comparator

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

Intervention: Running (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Enhance physical performance verified by oxygen consumption measurement on treadmill(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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