Clinical trial NCT03516721: Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology
Official title: Chronotropic Incompetence During Exercise and Relations With Development of Cardiovascular Disease in Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Adolescent Obesity
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2018-05-04
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A reduction in peak heart rate (HR) and suppressed HR response during exercise is highly prevalent in obese populations. This phenomenon is also known as chronotropic incompetence (CI). In adult obese individuals, CI is independently related to elevated risk for major adverse cardiovascular events and premature death. Despite the established association between CI and prognosis in adult populations, the prognostic relevance of CI in adolescents with obesity has however deserved no attention, but is important. CI during exercise testing may indicate various, yet undetected anomalies, such as altered blood catecholamine and/or potassium concentrations during exercise, structural myocardial abnormalities or ventricular stiffness, impaired baroreflex sensitivity and cardiovascular autonomic dysfunction, atherosclerosis, or cardiac electrophysiological anomalies, which all have been detected in obese children and adolescents. However, whether CI during exercise testing may be a sensitive and specific indicator for these anomalies in obese adolescents has not been studied yet. In addition, the exact physiology behind obesity and development of heart disease remains to be studied in greater detail in obese adolescents. In this project, we examine the prevalence of CI (during maximal cardiopulmonary exercise testing, CPET) in 60 obese adolescents (aged 12-16 years) vs. 60 lean adolescents, and study the association between CI and changes in CPET parameters, lactate, catecholamine and potassium concentrations during CPET, biochemical variables, and cardiac electrophysiology (by ECG recording). In addition, the relation between CI and cardiac function (echocardiography) will be examined in a subgroup (29 lean and 29 obese) of these adolescents. In this regard, the diagnostic value of HR (responses) during maximal exercise testing will be clarified in obese adolescents, and the physiology behind the elevated risk for heart disease in obese adolescents can be explored.


Eligibility criteria: Inclusion Criteria:

* aged 12-16 years
* obese or lean (based on extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity)
* Parental permission

Exclusion Criteria:

- Chronic cardiovascular, renal, pulmonary and orthopedic disease

Primary outcomes:
measure: Heart rate (HR)
timeFrame: day 1
measure: Ventilatory function
timeFrame: day 1
Secondary outcomes:
measure: height
timeFrame: day 1
measure: weight
timeFrame: day 1
measure: body composition
timeFrame: day 1
measure: PAQ-A (Physical Activity Questionaire for Adolescents)
timeFrame: day1
measure: Tanner scale
timeFrame: day 1
measure: Plasma glucose
timeFrame: day 1
measure: iron
timeFrame: day 1
measure: aspartate aminotransferase
timeFrame: day 1
measure: alanine aminotransferase
timeFrame: day 1
measure: gamma-glutamyl transpeptidase
timeFrame: day 1
measure: alkaline phosphatase
timeFrame: day 1
measure: uric acid
timeFrame: day 1
measure: calcium
timeFrame: day 1
measure: blood total cholesterol
timeFrame: day 1
measure: high-density lipoprotein cholesterol
timeFrame: day 1
measure: low-density lipoprotein cholesterol
timeFrame: day 1
measure: proteins
timeFrame: day 1
measure: triglyceride concentrations
timeFrame: day 1
measure: c-reactive proteine
timeFrame: day 1
measure: thyroid-stimulating hormone
timeFrame: day 1
measure: free thyroxine
timeFrame: day 1
measure: cortisol and serum insulin
timeFrame: day 1
measure: serum leptin concentration
timeFrame: day 1
measure: blood haemoglobin
timeFrame: day 1
measure: haematocrit
timeFrame: day 1
measure: leukocytes
timeFrame: day 1
measure: Echocardiography
timeFrame: day 1
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Hasselt University
name: Dominique Hansen, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: