Metabolic syndrome
Conditions
Interventions
Patients with metabolic syndrome from an urban community (London, Ontario) will be randomly assigned to either the combined aerobic-resistance exercise intervention or exercise control groups in an in
Sponsors
Aging, Rehabilitation & Geriatric Care Research Centre (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Aged 18 to 70 years 3. Presents with metabolic syndrome as defined by having SBP greater than 130 mmHg and/or DBP greater than 85 mmHg and any two of the following criteria: 3.1. Abdominal obesity (waist circumference greater than 102 cm in males; greater than 88 cm in females) 3.2. Fasting triglycerides greater than 1.695 mmol/L 4. Low HDL cholesterol: males less than 1.04 mmol/L; females less than 1.29 mmol/L 5. Fasting glucose greater than 5.60 mmol/L
Exclusion criteria
Exclusion criteria: Any patient who: 1. Has an in-clinic mean SBP greater than or equal to 180 mmHg and/or DBP greater than or equal to 110 mmHg 2. Has a history of myocardial infarction, angioplasty, coronary artery bypass, or cerebrovascular ischaemia/stroke 3. Has symptomatic congestive heart failure 4. Has atrial flutter 5. Has uncontrolled hypertension 6. Has unstable angina 7. Has unstable pulmonary disease (e.g., asthma or obstructive lung disease) 8. Uses medications known to affect heart rate (e.g., beta-blockers) 9. Has second or third degree heart block 10. Has a history of alcoholism, drug abuse, or other emotional, cognitive or psychiatric problem that is likely to impair compliance to the study 11. Requires the continuation of other medication which might interfere with the objectives of the study 12. Has a pacemaker 13. Has unstable metabolic disease (e.g. uncontrolled thyroid disease) 14. Has orthopaedic or rheumatologic problems that could impair ability to exercise 15. Has a history of allergy to any of the study drugs 16. Started, or changed dose of, a lipid lowering agent(s) within the previous 3 months 17. Is currently enrolled in a clinical research trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical blood pressure, recorded using a programmable automated device (BP-TRU™ 100 model, Vancouver, BC) 2. Blood glucose, lipid profiles, CRP and markers of RAS function: fasting blood glucose will be measured in the institutional setting using laboratory assays. In the rural setting, patients will use a remote monitoring glucometer (Bluetooth® enabled) as well as scheduled laboratory assays. Lipid profiles and CRP will be assessed using laboratory assays. Plasma catecholamines will be assessed by high pressure liquid chromatography whereas vasopressin, angiotensin and cortisol will be determined by radioimmunoassay approaches. 3. Predicted V02 max: subjects will perform a modified self-selected STEP™ test. Based on values of subject's height, weight, resting heart rate, training heart rate, and performance on the STEP™ test, V02 max values will be calculated. 4. Body composition, body mass index (BMI - kg/m^2), waist circumference All measured at baseline, 3, 6, 9 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 3D ultrasound measurement of carotid artery: patients will undergo a 3D ultrasound exam to assess the extent of their carotid atheromatous disease 2. Behavioural measures: surveys to examine changes in behaviour change with exercise interventions and quality of life, i.e., stage of change, self efficacy, decisional balance, SF-36 3. Physiological measures: 3.1. Cardiac function: standard echocardiographic approaches using B-mode and M-mode echo Doppler imaging will be performed by a certified echocardiographic technologist. Image location and gain settings will be adjusted to yield optimal definition of endocardial and epicardial borders. Chamber and wall dimensions will be measured according to the standard methods of the American Society of Echocardiography and left ventricular (LV) fractional shortening will be calculated from the difference between systolic and diastolic cavity dimensions over 3 cardiac cycles at end diastole taken at the QRS peak. LVM will be calculated according to the method of Devereux et. al. and normalised to body surface area (BSA). Left ventricular diastolic filling will be assessed in the left lateral decubitus position (supine) or sitting (upright) and data manually traced and digitised from 5 cardiac cycles in each subject. Pulsed Doppler transmitral flow velocities will be taken from the apical 4-chamber view between the tips of the mitral valve leaflets. Doppler data will be manually traced and digitised in each subject. Measures of peak early flow velocity (E), atrial flow velocity (A), isovolumic relaxation time (IVRT) and early deceleration time (DT) will be recorded at a sweep speed of 50 or 100mm/s. Intimal-media thickness of the right common carotid artery will be assessed with longitudinal B-mode images of the carotid artery in the patient's supine position with the head turned 45 degrees away from the side examined at a straight portion of the artery 1 - 2 cm proximal to the bifurcation. 3.2. Vascular properties: major c | — |
Countries
Canada
Outcome results
None listed