Effect of Physical Exercise on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Endothelial dysfunction precedes the development of cardiovascular disease and it is common
      in patients with diabetes mellitus. The aim of this study is to identify the effect of two
      different physical training programs, using ultrasound techniques, on the endothelial
      function of patients with type 2 DM.
    

Detailed description: 
      Subjects Subjects with type 2 DM, of both genders, aged between 40 and 65 years, without
      coronary artery disease, characterized by a negative maximum exercise test, will be studied.
      This study will be carried out at the Prevention and Cardiovascular Rehabilitation Unit
      Unicardio, in Hospital Santa Catarina, in the city of Blumenau, State of Santa Catarina,
      South of Brazil. The patients will be invited to participate in the study as they are treated
      at the clinic during regular medical consultations, with approximately 235 patients per
      month. After that, patient randomization will be carried out, by dividing the patients in the
      groups: intervention (a group undergoing high-intensity exercise and another one undergoing
      low-intensity exercise) and control group (patients not submitted to the physical exercise
      program, but went to the health care center to undergo blood pressure and heart rate
      measurement).

      The following exclusion criteria will be used: subjects in whom, for reasons related to
      clinical screening, it is not possible to withdrawn medications with known endothelial
      function effect, such as angiotensin-converting enzyme inhibitors, calcium channel blockers,
      nitrates, beta-blockers, anti-oxidizers, hormonal replacement therapy, insulin; subjects with
      altered maximum exercise test (positive); cigarette smoking history in the last 12 months;
      participation in a physical exercise program in the last 12 months; chronic obstructive
      pulmonary disease; high blood pressure levels (systolic blood pressure > 180mmHg and
      diastolic blood pressure > 110mmHg); osteoporosis and diabetic neuropathy.

      The study protocol is in accordance with the Declaration of Helsinki. All participants will
      be informed of the objectives of the study and possible risks and discomforts involved with
      their participation in the experiments, and will be included only after signing the informed
      consent term. The study protocol was approved by the Ethics Committee of Hospital Santa
      Catarina (Blumenau, Santa Catarina, Brazil).

      Study Protocol All study subjects will undergo an initial clinical examination performed by a
      cardiologist. Before and after 6 weeks of intervention, the patients will undergo the maximum
      exercise test, physical examination and endothelial function evaluation. The participants
      will be submitted to a program of physical exercise in the Prevention and Cardiovascular
      Rehabilitation Unit Unicardio of Hospital Santa Catarina, in Blumenau, Brazil. After the
      maximum exercise test is limited by fatigue, the participants will be referred, based on
      their individual exercise prescription and randomized to a low (50 to 60% of maximum heart
      rate) or high intensity (75 to 85% of maximum heart rate) exercise program. During the study
      period, the patients should maintain the same doses of medications.

      All patients will undergo a non-invasive evaluation of endothelial function, performed at
      Clínica Uniangio, in the city of Blumenau, Brazil. Two investigators will perform all the
      tests, while blinded to the group the patients were randomized to. All patients will undergo
      an 8-12 hour period of food and water deprivation. The individuals will be placed in the
      supine position, with the arms placed along the body in a comfortable position to obtain
      image of the brachial artery, above the antecubital fossa, in the longitudinal plane.

      An ultrasonic sound wave equipment will be used (Acuson, Model 128XP System, Mountain View,
      California, USA), with vascular software for two-dimensional images (2D), color Doppler with
      an internal electrocardiogram (ECG) monitor and a high-frequency vascular transducer (Acuson,
      Model L7 7,5-10 MHz, Mountain View, California, USA). After positioned, a segment with
      anterior and posterior interfaces with the arterial wall will be selected for 2D images.
      Arterial diameter values will be recorded in super-VHS for subsequent analysis.
    

Intervention name(s): High-intensity exercise; Low-intensity exercise
Intervention type(s): Procedure; Procedure
Intervention description(s): Performance of high-intensity exercise; Performance of low-intensity exercise
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Diabetes Mellitus.