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Trial record 1 of 1 for:    NCT02441504
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Effects of Low Intensity Aerobic Exercise on the Microvascular Endothelial Function of Patients With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02441504
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 13, 2015
Rio de Janeiro State University
Information provided by (Responsible Party):
ROGER DE MORAES, Instituto Nacional de Cardiologia de Laranjeiras

Brief Summary:

Background: The aim of the present study was to evaluate the changes in the microvascular density and reactivity in patients with type 1 diabetes (T1D) resulting from low intensity chronic exercise training.

Methods: This study included 22 (34 ± 7 years) consecutive outpatients with T1D and disease duration > six years. We used intravital video-microscopy to measure the basal skin capillary density as well as capillary recruitment using post-occlusive reactive hyperemia (PORH) in the dorsum of the fingers. Endothelium-dependent and -independent vasodilation of the skin microcirculation was evaluated in the forearm with a laser Doppler perfusion monitoring (LDPM) system in combination with acetylcholine and sodium nitroprusside iontophoresis, PORH and local thermal hyperemia.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: Low intensity Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Low Intensity Aerobic Exercise Training on the Microvascular Endothelial Function of Patients With Type 1 Diabetes: a Non-pharmacological Interventional Study
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Low intensity exercise
physical inactivity
Other: Low intensity Exercise
aerobic exercise training using walking and running

Primary Outcome Measures :
  1. Change in Cutaneous Capillary Density in twelve weeks of aerobic physical activity [ Time Frame: before and after 12 weeks of aerobic physical activity ]
    Chronic aerobic exercise has been involved in angiogenic processes that result in increased perfusion and capillary density. We believe that 12 weeks of aerobic exercise of low intensity is also able to exert the same effects in type 1diabetics patients. The microvascular cutaneous reactivity was studied by laser Doppler perfusion monitoring (LDPM), a method that has previously been standardized and validated. The capillary density, defined as the number of perfused capillaries per mm2 of skin area, was assessed by high-resolution intra-vital color microscopy using a video microscopy system with an epi-illuminated fiber optic microscope containing a 100-W mercury vapor lamp light source and an M200 objective with a final magnification of 200X.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Eligibility Gender: only male participants are being studied

Age Limits

Minimum 25 years

Maximum Age 50 years

Accepts Healthy Volunteers? no

Eligibility Criteria

Inclusion Criteria:

  • Individuals with type 1 diabetes diagnosed for more than 6 years
  • Age: between 25 and 50 years of age

Exclusion Criteria:

  • Chronic renal disease

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ROGER DE MORAES, Dr. PhD, Instituto Nacional de Cardiologia de Laranjeiras Identifier: NCT02441504    
Other Study ID Numbers: 1988-CEP/HUPE
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by ROGER DE MORAES, Instituto Nacional de Cardiologia de Laranjeiras:
Exercise training
microvascular rarefaction
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases