Skip to content

Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology

Chronotropic Incompetence During Exercise and Relations With Development of Cardiovascular Disease in Obese Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03516721
Acronym
CICO
Enrollment
120
Registered
2018-05-04
Start date
2016-11-01
Completion date
2019-08-31
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Obesity, Obesity

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.

Interventions

OTHERthe prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET

Sponsors

Jessa Hospital
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Heart rate (HR)day 1Assessed using a 12-lead ECG device
Ventilatory functionday 1Determined during maximal cardiopulmonary exercise testing.

Secondary

MeasureTime frameDescription
body compositionday 1
PAQ-A (Physical Activity Questionaire for Adolescents)day1physical activity determined using the validated Dutch physical activity questionnaire for adolescents
Tanner scaleday 1Puberty stage (ranging from 1 to 5) will be assessed in all participants by the pediatric endocrinologist using Tanner staging criteria. Boys - development of external genitalia Girls - breast development Boys and girls - pubic hair
Plasma glucoseday 1blood analyses
ironday 1blood analyses
aspartate aminotransferaseday 1blood analyses
alanine aminotransferaseday 1blood analyses
gamma-glutamyl transpeptidaseday 1blood analyses
alkaline phosphataseday 1blood analyses
uric acidday 1blood analyses
calciumday 1blood analyses
blood total cholesterolday 1blood analyses
heightday 1
low-density lipoprotein cholesterolday 1blood analyses
proteinsday 1blood analyses
triglyceride concentrationsday 1blood analyses
c-reactive proteineday 1blood analyses
thyroid-stimulating hormoneday 1blood analyses
free thyroxineday 1blood analyses
cortisol and serum insulinday 1blood analyses
serum leptin concentrationday 1blood analyses
blood haemoglobinday 1blood analyses
haematocritday 1blood analyses
leukocytesday 1blood analyses
Echocardiographyday 1Assessment left ventricular structure and systolic and diastolic function
high-density lipoprotein cholesterolday 1blood analyses
weightday 1

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026