Type 2 DiabetesNCT02554643
Soccer and Health: Diet and Exercise on Type 2 Diabetes Mellitus
A study testing Diet, Soccer and Running in people with Type 2 Diabetes, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diet, Soccer and Running
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Medical Investigation - LIM 18, University of São Paulo
São Paulo, São Paulo, 01246-903
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Diet, Soccer, Running
- Keywords
- intermittent exercise, continuous exercise, blood glucose, intramyocellular lipids, diabetes, gene expression
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Nutrition intervention, once a week during 12 weeks
SoccerOther
Nutrition intervention, once a week during 12 weeks + Soccer training, 3 x week, during 12 weeks
RunningOther
Nutrition intervention, once a week during 12 weeks + Running training, 3 x week, during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Diet & Soccer | Experimental | Nutritional Intervention (Diet) once a week, during 12 weeks
+ Soccer training, 3 times a week, during 12 weeks Receives: 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 Receives: Other: Diet; Other: Running |
| Diet | Active comparator | Nutritional Intervention (Diet) once a week, during 12 weeks Receives: Other: Soccer; Other: Running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attenuation of expression of proinflammatory genes verified by qPCR-array technique ranging from at least 5% in pre and post-intervention measurements
Measured: 12 weeks
Secondary outcomes (1)
Enhance physical performance verified by oxygen consumption measurement on treadmill
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maysa Sousa, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554643
- Sponsor's protocol ID
- Exercise on Type 2 Diabetes
- Status last verified
- Sep 2015
- First submitted
- 17 Sep 2015
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soccer and Health: Impact of Nutritional Intervention and Recreational Soccer Training in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02554643
- Acronym / sponsor ID
- Exercise on Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Keywords
- intermittent exercise, continuous exercise, blood glucose, intramyocellular lipids, diabetes, gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet & Soccer | Experimental | Other: Diet, Other: SoccerNutritional Intervention (Diet) once a week, during 12 weeks + Soccer training, 3 times a week, during 12 weeks |
| Diet & Running | Experimental | Other: Diet, Other: RunningNutritional Intervention (Diet) once a week, during 12 weeks + Running training, 3 times a week, during 12 weeks |
| Diet | Active comparator | Other: Soccer, Other: RunningNutritional Intervention (Diet) once a week, during 12 weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietNutrition intervention, once a week during 12 weeks | Other | Diet & Running, Diet & Soccer |
| SoccerNutrition intervention, once a week during 12 weeks + Soccer training, 3 x week, during 12 weeks | Other | Diet, Diet & Soccer |
| RunningNutrition intervention, once a week during 12 weeks + Running training, 3 x week, during 12 weeks | Other | Diet, Diet & Running |
Primary outcome
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
1 secondary outcome
Enhance physical performance verified by oxygen consumption measurement on treadmill
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maysa Sousa principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Soccer and Running in people with Type 2 Diabetes, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.