ObesityCICONCT03516721
Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology
A study testing the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET in people with Obesity and Adolescent Obesity, run by Hasselt University at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent Obesity
- What is being tested?
- the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2016to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged 12-16 years
- obese or lean (based on extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity)
- Parental permission
Who cannot join
- Chronic cardiovascular, renal, pulmonary and orthopedic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronotropic Incompetence During Exercise and Relations With Development of Cardiovascular Disease in Obese Adolescents
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.
- Conditions
- Obesity, Adolescent Obesity
- Being tested
- the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPETOther
| Study group | Role | What they receive |
|---|---|---|
| Obese adolescents | Other | Not described Receives: Other: the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET |
| Lean adolescents | Other | Not described Receives: Other: the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate (HR)
Assessed using a 12-lead ECG device
Measured: day 1
Ventilatory function
Determined during maximal cardiopulmonary exercise testing.
Measured: day 1
Secondary outcomes (27)
height
Measured: day 1
weight
Measured: day 1
body composition
Measured: day 1
PAQ-A (Physical Activity Questionaire for Adolescents)
physical activity determined using the validated Dutch physical activity questionnaire for adolescents
Measured: day1
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
Measured: day 1
Plasma glucose
blood analyses
Measured: day 1
iron
blood analyses
Measured: day 1
aspartate aminotransferase
blood analyses
Measured: day 1
alanine aminotransferase
blood analyses
Measured: day 1
gamma-glutamyl transpeptidase
blood analyses
Measured: day 1
alkaline phosphatase
blood analyses
Measured: day 1
uric acid
blood analyses
Measured: day 1
calcium
blood analyses
Measured: day 1
blood total cholesterol
blood analyses
Measured: day 1
high-density lipoprotein cholesterol
blood analyses
Measured: day 1
low-density lipoprotein cholesterol
blood analyses
Measured: day 1
proteins
blood analyses
Measured: day 1
triglyceride concentrations
blood analyses
Measured: day 1
c-reactive proteine
blood analyses
Measured: day 1
thyroid-stimulating hormone
blood analyses
Measured: day 1
free thyroxine
blood analyses
Measured: day 1
cortisol and serum insulin
blood analyses
Measured: day 1
serum leptin concentration
blood analyses
Measured: day 1
blood haemoglobin
blood analyses
Measured: day 1
haematocrit
blood analyses
Measured: day 1
leukocytes
blood analyses
Measured: day 1
Echocardiography
Assessment left ventricular structure and systolic and diastolic function
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Nov 2016
- Primary completion1 May 2017
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Dominique Hansen, prof. dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516721
- Sponsor's protocol ID
- CICO-001
- Acronym
- CICO
- Status last verified
- Nov 2019
- First submitted
- 16 Apr 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronotropic Incompetence During Exercise and Relations With Development of Cardiovascular Disease in Obese Adolescents
- ClinicalTrials.gov ID
- NCT03516721
- Acronym / sponsor ID
- CICO / CICO-001
- Conditions
- Obesity, Adolescent Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese adolescents | Other | Other: the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET |
| Lean adolescents | Other | Other: the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- aged 12-16 years
- obese or lean (based on extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity)
- Parental permission
Key exclusion criteria (1 listed)
- Chronic cardiovascular, renal, pulmonary and orthopedic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET | Other | Lean adolescents, Obese adolescents |
Primary outcome
Heart rate (HR)
Time frame: day 1
Assessed using a 12-lead ECG device
Ventilatory function
Time frame: day 1
Determined during maximal cardiopulmonary exercise testing.
27 secondary outcomes
height
Time frame: day 1
weight
Time frame: day 1
body composition
Time frame: day 1
PAQ-A (Physical Activity Questionaire for Adolescents)
Time frame: day1
Tanner scale
Time frame: day 1
Plasma glucose
Time frame: day 1
iron
Time frame: day 1
aspartate aminotransferase
Time frame: day 1
alanine aminotransferase
Time frame: day 1
gamma-glutamyl transpeptidase
Time frame: day 1
alkaline phosphatase
Time frame: day 1
uric acid
Time frame: day 1
calcium
Time frame: day 1
blood total cholesterol
Time frame: day 1
high-density lipoprotein cholesterol
Time frame: day 1
low-density lipoprotein cholesterol
Time frame: day 1
proteins
Time frame: day 1
triglyceride concentrations
Time frame: day 1
c-reactive proteine
Time frame: day 1
thyroid-stimulating hormone
Time frame: day 1
free thyroxine
Time frame: day 1
cortisol and serum insulin
Time frame: day 1
serum leptin concentration
Time frame: day 1
blood haemoglobin
Time frame: day 1
haematocrit
Time frame: day 1
leukocytes
Time frame: day 1
Echocardiography
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Hansen, prof. dr. principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET in people with Obesity and Adolescent Obesity, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (HR) (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.