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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03516721
Other study ID # CICO-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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