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Completed

NCT Number: NCT01956357

Chronic Effects of Two Aerobic-training Models Performed in Water and on Dry Land in Patients With Type 2 Diabetes Mellitus (T2DM).

The aim of this study was to analyse the acute and chronic effects of two aerobic-training models performed in water and on dry land on cardiorespiratory, functional, metabolic, hormonal and quality-of-life parameters in patients with type 2 diabetes mellitus (T2DM).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Education School of Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande Do Sil, 90690-200, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The clinical diagnosis of type 2 diabetes mellitus. Not be performing regular and systematic physical exercise for at least three months.

Exclusion criteria

Uncontrolled hypertension. Autonomic neuropathy. Severe peripheral neuropathy. Proliferative diabetic retinopathy. Severe nonproliferative diabetic retinopathy. Uncompensated heart failure. Peripheral amputations. Chronic renal failure (GFR by MDRD <30). Muscle or joint injury that prevents physical exercises.

Treatment and study plan

Aquatic Exercise

Other

Land Exercise

Other

Primary outcomes

  1. Glycated hemoglobin

    Time frame: Baseline and after 12 weeks of intervention

Secondary outcomes

  1. Fasting plasma glucose.

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  2. Postprandial glucose

    Time frame: Baseline and after 12 weeks of intervention.

  3. Fasting insulin.

    Time frame: Baseline and after 12 weeks of intervention.

  4. Insulin resistance (HOMA-IR).

    Time frame: Baseline and after 12 weeks of intervention.

  5. Total cholesterol.

    Time frame: Baseline and after 12 weeks of intervention.

  6. High density lipoprotein.

    Time frame: Baseline and after 12 weeks of intervention.

  7. Low density lipoprotein.

    Time frame: Baseline and after 12 weeks of intervention.

  8. Triglycerides.

    Time frame: Baseline and after 12 weeks of intervention.

  9. Plasma renin activity.

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  10. Angiotensin II.

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  11. C-reactive protein ultrasensitive.

    Time frame: Baseline and after 12 weeks of intervention.

  12. 8-isoprostane

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  13. Content of reative species (DCF)

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  14. Water-soluble Fluorescent Substances

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  15. Oxidation of tyrosine residues

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  16. Oxidation of tryptophan

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  17. superoxide dismutase (SOD)

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  18. Catalase (CAT)

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  19. Glutathione peroxidase (GPX)

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  20. Total radical-trapping antioxidant potential (TRAP)

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  21. Interleukin 1β

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  22. Interleukin 10

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  23. Leukocyte DNA Methylation

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  24. Purines

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  25. Interleukin 6

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  26. Global Histone Deacetylases activity

    Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

Other outcomes

  1. Peak oxygen consumption.

    Time frame: Baseline and after 12 weeks of intervention.

  2. Timed up and go in habitual speed and maximal speed.

    Time frame: Baseline and after 12 weeks of intervention.

  3. Oxygen uptake at ventilatory threshold.

    Time frame: Baseline and after 12 weeks of intervention.

  4. Percentage of oxygen consumption at ventilatory threshold.

    Time frame: Baseline and after 12 weeks of intervention.

  5. Systolic blood pressure.

    Time frame: Baseline and after 12 weeks of intervention.

  6. Diastolic blood pressure

    Time frame: Baseline and after 12 weeks of intervention.

  7. Resting heart rate.

    Time frame: Baseline and after 12 weeks of intervention.

  8. Quality of life.

    Time frame: Baseline and after 12 weeks of intervention.

  9. Depressive symptoms.

    Time frame: Baseline and after 12 weeks of intervention.

  10. Sleep quality.

    Time frame: Baseline and after 12 weeks of intervention.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
First posted
Oct 8, 2013
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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