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

Sponsor
Hasselt University (Other)
Overall Status
Completed
CT.gov ID
NCT03516721
Collaborator
Jessa Hospital (Other)
120
1
2
33.9
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Chronotropic Incompetence During Exercise and Relations With Development of Cardiovascular Disease in Obese Adolescents
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
Aug 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Obese adolescents

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

Other: Lean adolescents

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

Outcome Measures

Primary Outcome Measures

  1. Heart rate (HR) [day 1]

    Assessed using a 12-lead ECG device

  2. Ventilatory function [day 1]

    Determined during maximal cardiopulmonary exercise testing.

Secondary Outcome Measures

  1. height [day 1]

  2. weight [day 1]

  3. body composition [day 1]

  4. PAQ-A (Physical Activity Questionaire for Adolescents) [day1]

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

  5. Tanner scale [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 [day 1]

    blood analyses

  7. iron [day 1]

    blood analyses

  8. aspartate aminotransferase [day 1]

    blood analyses

  9. alanine aminotransferase [day 1]

    blood analyses

  10. gamma-glutamyl transpeptidase [day 1]

    blood analyses

  11. alkaline phosphatase [day 1]

    blood analyses

  12. uric acid [day 1]

    blood analyses

  13. calcium [day 1]

    blood analyses

  14. blood total cholesterol [day 1]

    blood analyses

  15. high-density lipoprotein cholesterol [day 1]

    blood analyses

  16. low-density lipoprotein cholesterol [day 1]

    blood analyses

  17. proteins [day 1]

    blood analyses

  18. triglyceride concentrations [day 1]

    blood analyses

  19. c-reactive proteine [day 1]

    blood analyses

  20. thyroid-stimulating hormone [day 1]

    blood analyses

  21. free thyroxine [day 1]

    blood analyses

  22. cortisol and serum insulin [day 1]

    blood analyses

  23. serum leptin concentration [day 1]

    blood analyses

  24. blood haemoglobin [day 1]

    blood analyses

  25. haematocrit [day 1]

    blood analyses

  26. leukocytes [day 1]

    blood analyses

  27. Echocardiography [day 1]

    Assessment left ventricular structure and systolic and diastolic function

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jessa Ziekenhuis Hasselt Belgium 3500

Sponsors and Collaborators

  • Hasselt University
  • Jessa Hospital

Investigators

  • Principal Investigator: Dominique Hansen, prof. dr., Hasselt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dominique Hansen, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier:
NCT03516721
Other Study ID Numbers:
  • CICO-001
First Posted:
May 4, 2018
Last Update Posted:
Feb 11, 2020
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2020