Clinical trial NCT04310371: Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise (CARDIBOX)
Official title: Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Adolescent Obesity
Keywords: left myocardial regional function
cardiac ectopic fat deposits
lifestyle programm
prevention
Adolescent Obesity
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Université d'Auvergne
name: LaPSCo laboratory, Physiological and Psychosocial Stress, UMR CNRS 6024, Clermont-Ferrand, France
name: LaPEC laboratory (EA 4278), University of Avignon, Avignon, France
name: Child Medical Center, 3 Rue de la Prugne, 63540 Romagnat, France
name: Tza-Nou Center, 230 Rue Vercingétorix, 63150 La Bourboule, France
First posted: 2020-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants receive an intervention throughout the protocol
Primary purpose: PREVENTION

Brief summary: The high prevalence of childhood obesity is a major public health issue, worldwide. Childhood obesity is associated with a high risk of cardiovascular events in adulthood, but recent studies also point out the development of cardiovascular complications in childhood or adolescence justifying the need for early detection and appropriate therapeutic management to prevent the development of more severe abnormalities. This project proposes to evaluate the myocardial function in a fine and comprehensive way (longitudinal, circumferential and radial linear deformations, and rotation / torsion mechanics) from the deformation imaging (MRI and high-resolution echocardiography), in obese adolescents following a lifestyle intervention combining diet and physical activity.

Detailed description: The investigators aim to improve knowledge of the association between epicardial adipose tissue, myocardial lipid content, and left ventricular regional myocardial function.

In this protocol, obese adolescents are recruited undergoing a 3-month lifestyle intervention residential program. Adolescents from the intervention group will be enrolled at the obesity center for the whole school year. The obesity center employs a multidisciplinary team to provide the best weight management care to adolescents during their stay. The weight loss program is an integral part of the obesity center program and fundamentally combines physical activity with a normocaloric diet monitored by a dietician. The physical activity program consists of two training sessions (aerobic and resistance training) per week. Moreover, adolescents will be engaged in two additional sessions per week, consisting in recreational activities such as ball and racquet games, trekking, snowshoeing or swimming.

There will be two measurement time: one at baseline (Day 0) and one at three months after the beginning of the lifestyle intervention (M3). The controls will be evaluated at baseline only.

Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p inferior to 0.05 will be considered significant. Qualitative variables will be described in terms of numbers and proportions. Quantitative variables will be described in terms of numbers, mean standard deviation or median according to statistical distribution (normality studied using Shapiro-Wilk test). Graphic representations will be complete presentations of results. The main analysis will be performed with the Stata software (version 13, StataCorp, College Station). All statistical tests will be carried out at a risk of error of first species α set at 5%. Most of the analysis of the secondary evaluation criteria will be exploratory in nature and may lack power in terms of numbers. As discussed by Feise in 2002,104 the adjustment of the risk of error of 1st species will not be systematically proposed, but case by case in view of clinical considerations and not only statistical (e.g. Sidak correction for the analysis of correlation coefficients).

Qualitative variables will be described in terms of numbers and proportions. Quantitative variables will be described in terms of standard deviation or mean median according to statistical distribution (normality studied using Shapiro-Wilk test). Graphic representations will be complete presentations of results.

Intergroup comparisons will be systematically conducted without adjustment and by adjusting for factors whose distribution could be unbalanced between groups. Patients will be described and compared between groups at inclusion according to the following variables: compliance with eligibility criteria, epidemiological characteristics, clinical characteristics and characteristics of possible treatments. The baseline comparability of the two groups will be assessed on the main characteristics of the participants and potential factors associated with the primary outcome. A possible difference between the two groups on one of these characteristics will be determined according to clinical considerations and not solely statistical ones.

Eligibility criteria: Inclusion Criteria:

* age between 12 and 16 years old
* mature (menarche)
* suitable for physical activity
* able to give an informative consent
* affiliated at French insurance company
* consent from the legal representatives
* For obese adolescents: BMI greater than the 97th percentile of national curves.
* For the control group: to be normal-weighted (no obesity if overweight, \<85th percentile of national curves).

Exclusion Criteria:

* Medical or surgical history judged by the investigator as incompatible with the study
* Drugs that may interfere with the study results
* Cardiovascular, hepatic, psychiatric, renal, or endocrinological diseases
* Smoking
* Alcohol consumption
* Intense physical activity in competition

Primary outcomes:
measure: cardiac ectopic fat deposits
timeFrame: Month 3
measure: cardiac ectopic fat deposits
timeFrame: Day 0
measure: cardiac ectopic fat deposits
timeFrame: Day 0
measure: cardiac ectopic fat deposits
timeFrame: Month 3
measure: cardiac ectopic fat deposits
timeFrame: Month 3
measure: cardiac ectopic fat deposits
timeFrame: Day 0
measure: left myocardial regional function
timeFrame: Month 3
measure: left myocardial regional function
timeFrame: Month 3
measure: left myocardial regional function
timeFrame: Day 0
measure: left myocardial regional function
timeFrame: Day 0
Secondary outcomes:
measure: macrovascularisation
timeFrame: Day 0
measure: macrovascularisation
timeFrame: Month 3
measure: microvascularisation
timeFrame: Month 3
measure: microvascularisation
timeFrame: Day 0
measure: microvascularisation
timeFrame: Day 0
measure: microvascularisation
timeFrame: Month 3
measure: microvascularisation
timeFrame: Month 3
measure: microvascularisation
timeFrame: Day 0
measure: microvascularisation
timeFrame: Day 0
measure: microvascularisation
timeFrame: Month 3
measure: heart rate variability
timeFrame: Month 3
measure: heart rate variability
timeFrame: Day 0
measure: skin conductance
timeFrame: Day 0
measure: skin conductance
timeFrame: Month 3
measure: Liver steatosis
timeFrame: Month 3
measure: Liver steatosis
timeFrame: Day 0
measure: Liver steatosis
timeFrame: Day 0
measure: Liver steatosis
timeFrame: Month 3
measure: Liver steatosis
timeFrame: month 3
measure: Liver steatosis
timeFrame: Day 0
measure: Liver fibrosis
timeFrame: Day 0
measure: Liver fibrosis
timeFrame: Month 3
measure: Liver fibrosis
timeFrame: Month 3
measure: Liver fibrosis
timeFrame: Day 0
measure: blood pressure
timeFrame: Day0
measure: blood pressure
timeFrame: month 3
measure: Fitness
timeFrame: Month 3
measure: Fitness
timeFrame: Day 0
measure: muscle mass
timeFrame: Month 3
measure: fat mass
timeFrame: Month 3
measure: bone structure
timeFrame: Month 3
measure: muscle mass
timeFrame: Day 0
measure: fat mass
timeFrame: Day 0
measure: bone structure
timeFrame: Day 0
measure: muscle mass
timeFrame: Day 0
measure: fat mass
timeFrame: Day 0
measure: bone structure
timeFrame: Day 0
measure: muscle mass
timeFrame: Month 3
measure: fat mass
timeFrame: Month 3
measure: bone structure
timeFrame: Month 3
measure: muscle mass
timeFrame: Month 3
measure: fat mass
timeFrame: Month 3
measure: bone structure
timeFrame: Month 3
measure: muscle mass
timeFrame: Day 0
measure: fat mass
timeFrame: Day 0
measure: bone structure
timeFrame: Day 0
measure: muscle mass
timeFrame: Day 0
measure: fat mass
timeFrame: Day 0
measure: bone structure
timeFrame: Day 0
measure: muscle mass
timeFrame: Month 3
measure: fat mass
timeFrame: Month 3
measure: bone structure
timeFrame: Month 3
measure: depression
timeFrame: Day 0
measure: depression
timeFrame: Month 3
measure: anxiety
timeFrame: Day 0
measure: anxiety
timeFrame: Month 3
measure: General health
timeFrame: Day 0
measure: General health
timeFrame: Month 3
measure: Stress
timeFrame: day 0
measure: Stress
timeFrame: Month 3
measure: Fatigue
timeFrame: Day 0
measure: Fatigue
timeFrame: Month 3
measure: Sleep
timeFrame: day 0
measure: Sleep
timeFrame: Month 3
measure: Burnout
timeFrame: day 0
measure: Burnout
timeFrame: Month 3
measure: Mindfulness
timeFrame: Day 0
measure: Mindfulness
timeFrame: Month 3
measure: Coping
timeFrame: Day 0
measure: Coping
timeFrame: Month 3
measure: Emotions
timeFrame: Day 0
measure: Emotions
timeFrame: Month 3
measure: Perception of work
timeFrame: Day 0
measure: Perception of work
timeFrame: Month 3
measure: Self-efficacy
timeFrame: Day 0
measure: Self-efficacy
timeFrame: Month 3
measure: Alexithymia
timeFrame: Day 0
measure: Alexithymia
timeFrame: Month 3
measure: Illness perception
timeFrame: Day 0
measure: Illness perception
timeFrame: Month 3
measure: Metacognition
timeFrame: Day 0
measure: Metacognition
timeFrame: Month 3
measure: Time perception
timeFrame: Day 0
measure: Time perception
timeFrame: Month 3
measure: Physical activity
timeFrame: Day 0
measure: Physical activity
timeFrame: Month 3
measure: Life style
timeFrame: Day 0
measure: Life style
timeFrame: Month 3
measure: cholesterol
timeFrame: Day 0
measure: triglycerides
timeFrame: Day 0
measure: cholesterol
timeFrame: Month 3
measure: triglycerides
timeFrame: Month 3
measure: Cortisol
timeFrame: Day 0
measure: Cortisol
timeFrame: Month 3
measure: DHEAS
timeFrame: day 0
measure: DHEAS
timeFrame: Month 3
measure: BDNF
timeFrame: Day 0
measure: BDNF
timeFrame: Month 3
measure: CRP
timeFrame: Day 0
measure: pro-inflammatory cytokines
timeFrame: Day 0
measure: TNF alpha
timeFrame: Day 0
measure: CRP
timeFrame: Month 3
measure: pro-inflammatory cytokines
timeFrame: Month 3
measure: TNF alpha
timeFrame: Month 3
measure: NPY
timeFrame: Month 3
measure: NPY
timeFrame: Day 0
measure: Leptin
timeFrame: Day 0
measure: Leptin
timeFrame: Month 3
measure: Ghrelin
timeFrame: Day 0
measure: Ghrelin
timeFrame: Month 3
measure: NPY
timeFrame: day 0
measure: NPY
timeFrame: Month 3
measure: adiponectine
timeFrame: Day 0
measure: adiponectine
timeFrame: Month 3
measure: CCK
timeFrame: Day 0
measure: Month 3
timeFrame: Day 0
measure: Insulin
timeFrame: Day 0
measure: Insulin
timeFrame: Month 3
measure: HbA1c
timeFrame: Day 0
measure: HbA1c
timeFrame: Month 3
measure: glucose
timeFrame: Day 0
measure: glucose
timeFrame: Month 3
measure: Albumin
timeFrame: Day 0
measure: Albumin
timeFrame: Month 3
measure: transthyretin
timeFrame: Day 0
measure: transthyretin
timeFrame: Month 3
measure: Homeostasis
timeFrame: Day 0
measure: Homeostasis
timeFrame: Month 3
measure: Osteoresorption
timeFrame: Day 0
measure: Osteoresorption
timeFrame: Month 3
measure: Osteoformation
timeFrame: Day 0
measure: Osteoformation
timeFrame: Month 3
measure: VEGF
timeFrame: Day 0
measure: VEGF
timeFrame: Month 3
measure: PAI1
timeFrame: Day 0
measure: PAI1
timeFrame: Month 3
measure: weight
timeFrame: Day 0
measure: weight
timeFrame: Month 3
measure: waist circumference
timeFrame: Day 0
measure: waist circumference
timeFrame: Month 3
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric Dutheil
role: PRINCIPAL_INVESTIGATOR
References: