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Completed

NCT Number: NCT03516721

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

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.

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Key information

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Primary outcomes

  1. Heart rate (HR)

    Time frame: day 1

    Assessed using a 12-lead ECG device

  2. Ventilatory function

    Time frame: day 1

    Determined during maximal cardiopulmonary exercise testing.

Secondary outcomes

  1. height

    Time frame: day 1

  2. weight

    Time frame: day 1

  3. body composition

    Time frame: day 1

  4. PAQ-A (Physical Activity Questionaire for Adolescents)

    Time frame: day1

    physical activity determined using the validated Dutch physical activity questionnaire for adolescents

  5. Tanner scale

    Time frame: day 1

    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

  6. Plasma glucose

    Time frame: day 1

    blood analyses

  7. iron

    Time frame: day 1

    blood analyses

  8. aspartate aminotransferase

    Time frame: day 1

    blood analyses

  9. alanine aminotransferase

    Time frame: day 1

    blood analyses

  10. gamma-glutamyl transpeptidase

    Time frame: day 1

    blood analyses

  11. alkaline phosphatase

    Time frame: day 1

    blood analyses

  12. uric acid

    Time frame: day 1

    blood analyses

  13. calcium

    Time frame: day 1

    blood analyses

  14. blood total cholesterol

    Time frame: day 1

    blood analyses

  15. high-density lipoprotein cholesterol

    Time frame: day 1

    blood analyses

  16. low-density lipoprotein cholesterol

    Time frame: day 1

    blood analyses

  17. proteins

    Time frame: day 1

    blood analyses

  18. triglyceride concentrations

    Time frame: day 1

    blood analyses

  19. c-reactive proteine

    Time frame: day 1

    blood analyses

  20. thyroid-stimulating hormone

    Time frame: day 1

    blood analyses

  21. free thyroxine

    Time frame: day 1

    blood analyses

  22. cortisol and serum insulin

    Time frame: day 1

    blood analyses

  23. serum leptin concentration

    Time frame: day 1

    blood analyses

  24. blood haemoglobin

    Time frame: day 1

    blood analyses

  25. haematocrit

    Time frame: day 1

    blood analyses

  26. leukocytes

    Time frame: day 1

    blood analyses

  27. Echocardiography

    Time frame: day 1

    Assessment left ventricular structure and systolic and diastolic function

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital

Registry information

Official study title

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

Acronym: CICO

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
May 4, 2018
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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