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

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956357
• Other study ID #: 54475
• Status: Completed
• Phase: N/A
• First received: September 27, 2013
• Last updated: November 4, 2014
• Start date: August 2012

Study information

• Verified date: May 2014
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Aquatic exercise

• Land Exercise

Locations

Country	Name	City	State
Brazil	Physical Education School of Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande do Sil

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peak oxygen consumption.		Baseline and after 12 weeks of intervention.	No
Other	Timed up and go in habitual speed and maximal speed.		Baseline and after 12 weeks of intervention.	No
Other	Oxygen uptake at ventilatory threshold.		Baseline and after 12 weeks of intervention.	No
Other	Percentage of oxygen consumption at ventilatory threshold.		Baseline and after 12 weeks of intervention.	No
Other	Systolic blood pressure.		Baseline and after 12 weeks of intervention.	No
Other	Diastolic blood pressure		Baseline and after 12 weeks of intervention.	No
Other	Resting heart rate.		Baseline and after 12 weeks of intervention.	No
Other	Quality of life.		Baseline and after 12 weeks of intervention.	No
Other	Depressive symptoms.		Baseline and after 12 weeks of intervention.	No
Other	Sleep quality.		Baseline and after 12 weeks of intervention.	No
Primary	Glycated hemoglobin		Baseline and after 12 weeks of intervention	No
Secondary	Fasting plasma glucose.		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Postprandial glucose		Baseline and after 12 weeks of intervention.	No
Secondary	Fasting insulin.		Baseline and after 12 weeks of intervention.	No
Secondary	Insulin resistance (HOMA-IR).		Baseline and after 12 weeks of intervention.	No
Secondary	Total cholesterol.		Baseline and after 12 weeks of intervention.	No
Secondary	High density lipoprotein.		Baseline and after 12 weeks of intervention.	No
Secondary	Low density lipoprotein.		Baseline and after 12 weeks of intervention.	No
Secondary	Triglycerides.		Baseline and after 12 weeks of intervention.	No
Secondary	Plasma renin activity.		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Angiotensin II.		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	C-reactive protein ultrasensitive.		Baseline and after 12 weeks of intervention.	No
Secondary	8-isoprostane		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Content of reative species (DCF)		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Water-soluble Fluorescent Substances		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Oxidation of tyrosine residues		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Oxidation of tryptophan		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	superoxide dismutase (SOD)		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Catalase (CAT)		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Glutathione peroxidase (GPX)		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Total radical-trapping antioxidant potential (TRAP)		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Interleukin 1ß		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Interleukin 10		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Leukocyte DNA Methylation		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Purines		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Interleukin 6		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No
Secondary	Global Histone Deacetylases activity		Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.	No