Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology (CICO)
Primary Purpose
Obesity, Adolescent Obesity
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET
Sponsored by
About this trial
This is an interventional other trial for Obesity
Eligibility Criteria
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
Sites / Locations
- Jessa Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Obese adolescents
Lean adolescents
Arm Description
Outcomes
Primary Outcome Measures
Heart rate (HR)
Assessed using a 12-lead ECG device
Ventilatory function
Determined during maximal cardiopulmonary exercise testing.
Secondary Outcome Measures
height
weight
body composition
PAQ-A (Physical Activity Questionaire for Adolescents)
physical activity determined using the validated Dutch physical activity questionnaire for adolescents
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
Plasma glucose
blood analyses
iron
blood analyses
aspartate aminotransferase
blood analyses
alanine aminotransferase
blood analyses
gamma-glutamyl transpeptidase
blood analyses
alkaline phosphatase
blood analyses
uric acid
blood analyses
calcium
blood analyses
blood total cholesterol
blood analyses
high-density lipoprotein cholesterol
blood analyses
low-density lipoprotein cholesterol
blood analyses
proteins
blood analyses
triglyceride concentrations
blood analyses
c-reactive proteine
blood analyses
thyroid-stimulating hormone
blood analyses
free thyroxine
blood analyses
cortisol and serum insulin
blood analyses
serum leptin concentration
blood analyses
blood haemoglobin
blood analyses
haematocrit
blood analyses
leukocytes
blood analyses
Echocardiography
Assessment left ventricular structure and systolic and diastolic function
Full Information
NCT ID
NCT03516721
First Posted
April 16, 2018
Last Updated
February 10, 2020
Sponsor
Hasselt University
Collaborators
Jessa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03516721
Brief Title
Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology
Acronym
CICO
Official Title
Chronotropic Incompetence During Exercise and Relations With Development of Cardiovascular Disease in Obese Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
August 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese adolescents
Arm Type
Other
Arm Title
Lean adolescents
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET
Primary Outcome Measure Information:
Title
Heart rate (HR)
Description
Assessed using a 12-lead ECG device
Time Frame
day 1
Title
Ventilatory function
Description
Determined during maximal cardiopulmonary exercise testing.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
height
Time Frame
day 1
Title
weight
Time Frame
day 1
Title
body composition
Time Frame
day 1
Title
PAQ-A (Physical Activity Questionaire for Adolescents)
Description
physical activity determined using the validated Dutch physical activity questionnaire for adolescents
Time Frame
day1
Title
Tanner scale
Description
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
Time Frame
day 1
Title
Plasma glucose
Description
blood analyses
Time Frame
day 1
Title
iron
Description
blood analyses
Time Frame
day 1
Title
aspartate aminotransferase
Description
blood analyses
Time Frame
day 1
Title
alanine aminotransferase
Description
blood analyses
Time Frame
day 1
Title
gamma-glutamyl transpeptidase
Description
blood analyses
Time Frame
day 1
Title
alkaline phosphatase
Description
blood analyses
Time Frame
day 1
Title
uric acid
Description
blood analyses
Time Frame
day 1
Title
calcium
Description
blood analyses
Time Frame
day 1
Title
blood total cholesterol
Description
blood analyses
Time Frame
day 1
Title
high-density lipoprotein cholesterol
Description
blood analyses
Time Frame
day 1
Title
low-density lipoprotein cholesterol
Description
blood analyses
Time Frame
day 1
Title
proteins
Description
blood analyses
Time Frame
day 1
Title
triglyceride concentrations
Description
blood analyses
Time Frame
day 1
Title
c-reactive proteine
Description
blood analyses
Time Frame
day 1
Title
thyroid-stimulating hormone
Description
blood analyses
Time Frame
day 1
Title
free thyroxine
Description
blood analyses
Time Frame
day 1
Title
cortisol and serum insulin
Description
blood analyses
Time Frame
day 1
Title
serum leptin concentration
Description
blood analyses
Time Frame
day 1
Title
blood haemoglobin
Description
blood analyses
Time Frame
day 1
Title
haematocrit
Description
blood analyses
Time Frame
day 1
Title
leukocytes
Description
blood analyses
Time Frame
day 1
Title
Echocardiography
Description
Assessment left ventricular structure and systolic and diastolic function
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Hansen, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology
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