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

Obesity Clinical Trial

— CICO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516721
• Other study ID #: CICO-001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: November 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 31, 2019
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Obesity
• Obesity
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate (HR)	Assessed using a 12-lead ECG device	day 1
Primary	Ventilatory function	Determined during maximal cardiopulmonary exercise testing.	day 1
Secondary	height		day 1
Secondary	weight		day 1
Secondary	body composition		day 1
Secondary	PAQ-A (Physical Activity Questionaire for Adolescents)	physical activity determined using the validated Dutch physical activity questionnaire for adolescents	day1
Secondary	Tanner scale	Puberty 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	day 1
Secondary	Plasma glucose	blood analyses	day 1
Secondary	iron	blood analyses	day 1
Secondary	aspartate aminotransferase	blood analyses	day 1
Secondary	alanine aminotransferase	blood analyses	day 1
Secondary	gamma-glutamyl transpeptidase	blood analyses	day 1
Secondary	alkaline phosphatase	blood analyses	day 1
Secondary	uric acid	blood analyses	day 1
Secondary	calcium	blood analyses	day 1
Secondary	blood total cholesterol	blood analyses	day 1
Secondary	high-density lipoprotein cholesterol	blood analyses	day 1
Secondary	low-density lipoprotein cholesterol	blood analyses	day 1
Secondary	proteins	blood analyses	day 1
Secondary	triglyceride concentrations	blood analyses	day 1
Secondary	c-reactive proteine	blood analyses	day 1
Secondary	thyroid-stimulating hormone	blood analyses	day 1
Secondary	free thyroxine	blood analyses	day 1
Secondary	cortisol and serum insulin	blood analyses	day 1
Secondary	serum leptin concentration	blood analyses	day 1
Secondary	blood haemoglobin	blood analyses	day 1
Secondary	haematocrit	blood analyses	day 1
Secondary	leukocytes	blood analyses	day 1
Secondary	Echocardiography	Assessment left ventricular structure and systolic and diastolic function	day 1