- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01983007
Effect of Physical Exercise on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
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exclusion criteria will be used: subjects in whom, for reasons related to clinical screening, it is not possible to withdrawn medications with known endothelial function effect, such as angiotensin-converting enzyme inhibitors, calcium channel blockers, nitrates, beta-blockers,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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Santa Catarina
-
Blumenau, Santa Catarina, Brazil
- Prevention and Cardiovascular Rehabilitation Unit Unicardio, in Hospital Santa Catarina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: high-intensity exercise group
Patients undergoing high-intensity exercise group.
Intervention: high-intensity exercise.
|
Performance of high-intensity exercise
|
Experimental: low-intensity exercise group
Patients undergoing low-intensity exercise group Intervention: low-intensity exercise
|
Performance of low-intensity exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arterial dilation
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos Alberto Silva, PhD, Universidade Federal Do Ceara
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14343
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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