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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 October 2015 |
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Main ID: |
NCT02554643 |
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Date of registration:
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17/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Soccer and Health: Diet and Exercise on Type 2 Diabetes Mellitus
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Scientific title:
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Soccer and Health: Impact of Nutritional Intervention and Recreational Soccer Training in Patients With Type 2 Diabetes Mellitus |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02554643 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Maysa Sousa |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sao Paulo |
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Key inclusion & exclusion criteria
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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.
Age minimum:
50 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Intervention(s)
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Other: Diet
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Other: Running
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Other: Soccer
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Enhance physical performance verified by oxygen consumption measurement on treadmill
[Time Frame: 12 weeks]
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Secondary ID(s)
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Exercise on Type 2 Diabetes
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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