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

NCT02554643 | Completed DMC

• 1 other identifier: Exercise on Type 2 Diabetes
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

intermittent exercise; continuous exercise; blood glucose; intramyocellular lipids; diabetes; gene expression

Outcome Measures

Primary Outcomes (1)

• Attenuation of expression of proinflammatory genes verified by qPCR-array technique ranging from at least 5% in pre and post-intervention measurements

  12 weeks

Secondary Outcomes (1)

• Enhance physical performance verified by oxygen consumption measurement on treadmill

  12 weeks

Study Arms (3)

Diet & Soccer

EXPERIMENTAL

Nutritional Intervention (Diet) once a week, during 12 weeks \+ Soccer training, 3 times a week, during 12 weeks

Other: Diet; Other: Soccer

Diet & Running

EXPERIMENTAL

Nutritional Intervention (Diet) once a week, during 12 weeks \+ Running training, 3 times a week, during 12 weeks

Other: Diet; Other: Running

Diet

ACTIVE COMPARATOR

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

Other: Soccer; Other: Running

Interventions

Diet OTHER

Nutrition intervention, once a week during 12 weeks

Diet & Running; Diet & Soccer

Soccer OTHER

Nutrition intervention, once a week during 12 weeks + Soccer training, 3 x week, during 12 weeks

Diet; Diet & Soccer

Running OTHER

Nutrition intervention, once a week during 12 weeks + Running training, 3 x week, during 12 weeks

Diet; Diet & Running

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Laboratory of Medical Investigation - LIM 18, University of São Paulo

São Paulo, São Paulo, 01246-903, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Diet; Running

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Maysa Sousa

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 18, 2015
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

BR (1)