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

NCT03516721 | Completed

• 1 other identifier: CICO-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Heart rate (HR)

  Assessed using a 12-lead ECG device

  day 1

• Ventilatory function

  Determined during maximal cardiopulmonary exercise testing.

  day 1

Secondary Outcomes (27)

• height

  day 1

• weight

  day 1

• body composition

  day 1

• PAQ-A (Physical Activity Questionaire for Adolescents)

  day1

• Tanner scale

  day 1

Study Arms (2)

Obese adolescents

OTHER

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

Lean adolescents

OTHER

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

Interventions

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

Lean adolescents; Obese adolescents

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \- Chronic cardiovascular, renal, pulmonary and orthopedic disease

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Interventions

Clostridium perfringens epsilon-toxin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominique Hansen, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 4, 2018
• Study Start: November 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: August 31, 2019
• Last Updated: February 11, 2020

Record last verified: 2019-11

Locations

BE (1)