ANGIO-EX study: to determine whether the blood circulating protein angiopoietin like-2 (angptl2) is associated with a poor vessel health in young and old healthy volunteers, patients with a coronary artery heart disease and in obese subjects

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2013
INTERVENTION: Phase 1 will consist of measuring angptl2 in the blood extracted from two groups of healthy and physically trained volunteers (men and women) and a group of obese subject (men and women). At enrolment, participants provide written informed consent form and undergo a complete medical history and physical examination including measurement of anthropometric variables and body composition with bioelectrical impedance analysis (Tanita BC 418, Japan). A fasting blood profile (total cholesterol, HDL, LDL, triglycerides, free fatty acids, glycaemia, insulin, HbA1c, CRP) will be measured in the clinical biochemistry laboratory of the MHI, while angptl2 is measured by ELISA in the laboratory of Professor Thorin. Blood will be drawn between 8 and 9 a.m. On a separate, non‐fasting day, obese and healthy study participants will perform a maximal cardiopulmonary exercise test on a bicycle ergometer using an incremental protocol with gas exchange analysis. This test represents the gold standard assessment of maximal aerobic exercise capacity (VO2max). One week later, on a separate non‐fasting day, volunteers will perform one of the two‐planned isocaloric exercises test, a maximal intensity continuous exercise (MICE) or the high intensity interval exercise (HIIE) test. These tests will be performed at one‐week interval. Blood will be collected before, and 20 min, 24 and 72 hours after the end of the exercise test in non‐fasting condition (2 h after breakfast). MICE is a continuous cycling at 60% of VO2max. Electrocardiogram is continuously recorded and monitored for cardiac arrhythmias, and systolic arterial pressure is determined at 2 min intervals for abnormal blood pressure response during the 28‐min test. The HIIE is 35‐min long and consists of a standardized 5‐min warm‐up bout at 50% of mean arterial pressure followed by a set of three 10‐second bouts at 100% of VO2max interspersed by 1 min of active recovery at 50% of mean arterial pressure. A 5‐min passive recovery phase CONDITION: Aging and age‐related cardiovascular diseases ; Circulatory System ; Cardiovascular disease, unspecified PRIMARY OUTCOME: Measure of circulating levels of angptl2 SECONDARY OUTCOME: To demonstrate modifications in biomarkers including leukocyte epigenetic changes after a secondary prevention program INCLUSION CRITERIA: In phase 1, two groups (n=20 each) of healthy and physically trained volunteer members (men and women) of aged 18 to 39 years and 50 to 70 years. Obese subjects (n=20) aged 50 to 70 years, men and women. Healthy subjects are defined as men and women without cardiac, pulmonary or muscular diseases. Obese patients are recruited at a BMI >30 kg/m2, without cardiac, pulmonary and muscular disease. In phase 2 of the study, newly referred patients with CHD (n=20) aged 50 to 70 years, and obese subjects (n=20) aged 50 to 70 years, men and women. Inclusion criteria for CHD patients are: 1. Documented prior acute coronary syndrome 2. Documented coronary revascularization or documented myocardial ischemia or necrosis on myocardial scintigraphy. Obese patients are recruited at a BMI >30 kg/m2, without cardiac, pulmonary and muscular disease.
Epistemonikos ID: 6d5bb613231bfdb650cedb17b3af9e8feb3e8b0d
First added on: Aug 22, 2024