Cardiovascular Oscillations in Coronary Patients With and Without Type 2 Diabetes

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Diabetes Mellitus, Type 2
• Interventions: Other: Isometric exercise

• Registration Number: NCT02050399
• Lead Sponsor: Universidade Federal de Sao Carlos

Brief Summary

Coronary artery disease (CAD) and diabetes mellitus (DM) may promote alterations in heart responses during exercise or postural maneuver. Thus, the purpose of this study is to observe the influence of different postures (supine, seated and standing) and different percentages (15, 30, 45 and 60%) of the maximum voluntary contraction (MVC) of handgrip in the responses of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), cardiac output (CO), stroke volume (SV) and peripheral vascular resistance (PVR) in coronary patients with and without type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Status Verified: 2014-01
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-30
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• coronary artery disease
• clinical diagnosis of type 2 diabetes
• free of type 2 diabetes to participate of control group and coronary disease without Type 2 Diabetes group
• nonsmokers
• not alcoholics

Exclusion Criteria

• autonomic neuropathy
• clinical exercise testing with ECG alterations (ST-segment depression greater than 2 mm, ventricular and supraventricular arrhythmias, sustained or non-sustained supraventricular tachycardia, atrial tachycardia, atrial fibrillation and atrioventricular blocks) or symptom of angina induced by stress.
• Individuals with hypertension and diabetes mellitus not controlled.
• Subjects who did not complete all assessments.
• Subjects with temporal (R-Ri and pressure) series with noise preventing the evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Isometric exercise	15 men, 45 and 65 years old. After initial evaluation, clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood) and isometric exercise protocol will be performed.
Coronary disease without Type 2 Diabetes	Isometric exercise	15 men, 45-65 years old, with coronary artery disease will perform clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood) and isometric exercise will be performed.
Coronary disease with Type 2 Diabetes	Isometric exercise	15 men, 45-65 years old, with coronary artery disease and type 2 diabetes will perform clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood), clinical autonomic tests and isometric exercise protocol will be performed.

Primary Outcome Measures

Name	Time	Method
Cardiovascular responses during isometric exercise	Change in heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, cardiac output, stroke volume and peripheral resistance. [time frame: initial (10 min), during the time of contraction (peak) and after contraction (10 min)	15 men with coronary artery disease and 15 healthy subjects will perform isometric contractions (handgrip) in different percentages (15,30, 45 60%) of maximum voluntary contraction (MVC) and in different postures (supine, seated and standing position). The percentages and postures will be randomized and the subjects will perform two contractions per day in a posture. All the variables will be evaluated through pulse plethysmograph (Finometer PRO, Finapress Medical System, The Netherlands). The subjects will be assessed in the protocol of isometric exercise for six days (two contractions per day and one posture). Initially they will remain at rest for 10 minutes and wiil perform the percentage drawn of maximal voluntary contraction until exhaustion. After 10 minutes of recovery subjects will perform another percentage of maximum contraction to exhaustion.

Trial Locations

Locations (1)

Universidade Federal de São Carlos; 🇧🇷 São Carlos, São Paulo, Brazil