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

NCT ID: NCT03516721

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2019-08-31

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.

Conditions

Obesity; Adolescent Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Obese adolescents

Group Type: OTHER

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

Intervention Type: OTHER

Lean adolescents

Group Type: OTHER

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

Intervention Type: OTHER

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Dominique Hansen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominique Hansen, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

Jessa Ziekenhuis

Hasselt, , Belgium

Countries

Belgium

Other Identifiers

CICO-001

Identifier Type: -

Identifier Source: org_study_id