Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise (CARDIBOX)

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04310371
• Other study ID #: RBHP 2019 DUTHEIL
• Secondary ID: 2019-A01804-53
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: June 2021

Study information

• Verified date: February 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• 3-month lifestyle intervention
Adolescents from the intervention group will be enrolled at the obesity center for the whole school year (i.e., 10 months). The physical activity program consists of two training sessions (aerobic and resistance training) per week. 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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Child Medical Center, 3 Rue de la Prugne, 63540 Romagnat, France, LaPEC laboratory (EA 4278), University of Avignon, Avignon, France, LaPSCo laboratory, Physiological and Psychosocial Stress, UMR CNRS 6024, Clermont-Ferrand, France, Tza-Nou Center, 230 Rue Vercingétorix, 63150 La Bourboule, France, Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (thickness using echocardiography)	Month 3
Primary	cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (thickness using echocardiography)	Day 0
Primary	cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (volume using MRI)	Day 0
Primary	cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (volume using MRI)	Month 3
Primary	cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)	Month 3
Primary	cardiac ectopic fat deposits	Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)	Day 0
Primary	left myocardial regional function	left myocardial regional function (echocardiography)	Month 3
Primary	left myocardial regional function	left myocardial regional function (MRI)	Month 3
Primary	left myocardial regional function	left myocardial regional function (echocardiography)	Day 0
Primary	left myocardial regional function	left myocardial regional function (MRI)	Day 0
Secondary	macrovascularisation	measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound	Day 0
Secondary	macrovascularisation	measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound	Month 3
Secondary	microvascularisation	measure of blood flow velocity using laser speckle contrast imaging (LSCI)	Month 3
Secondary	microvascularisation	measure of blood flow velocity using laser speckle contrast imaging (LSCI)	Day 0
Secondary	microvascularisation	measure of microvascular perfusion using laser-Doppler flowmetry (LDF)	Day 0
Secondary	microvascularisation	measure of microvascular perfusion using laser-Doppler flowmetry (LDF)	Month 3
Secondary	microvascularisation	measure of microvascular perfusion using Iontophoresis procedure	Month 3
Secondary	microvascularisation	measure of microvascular perfusion using Iontophoresis procedure	Day 0
Secondary	microvascularisation	measure of microvascular perfusion using flowmotion	Day 0
Secondary	microvascularisation	measure of microvascular perfusion using flowmotion	Month 3
Secondary	heart rate variability	measure of heart rate variability using a holter	Month 3
Secondary	heart rate variability	measure of heart rate variability using a holter	Day 0
Secondary	skin conductance	measure of skin conductance using Wristband electrodes - Empatica E4	Day 0
Secondary	skin conductance	measure of skin conductance using Wristband electrodes - Empatica E4	Month 3
Secondary	Liver steatosis	measure of liver steatosis by MRI	Month 3
Secondary	Liver steatosis	measure of liver steatosis by MRI	Day 0
Secondary	Liver steatosis	measure of liver steatosis by fibroscanner (ultrasonic attenuation)	Day 0
Secondary	Liver steatosis	measure of liver steatosis by fibroscanner (ultrasonic attenuation)	Month 3
Secondary	Liver steatosis	measure of liver steatosis by Aixplorer (Lipersonic Imagine®)	month 3
Secondary	Liver steatosis	measure of liver steatosis by Aixplorer (Lipersonic Imagine®)	Day 0
Secondary	Liver fibrosis	measure of liver fibrosis by fibroscanner (liver stiffness)	Day 0
Secondary	Liver fibrosis	measure of liver fibrosis by fibroscanner (liver stiffness)	Month 3
Secondary	Liver fibrosis	measure of liver fibrosis by fibrotest (Lipersonic Imagine®)	Month 3
Secondary	Liver fibrosis	measure of liver fibrosis by fibrotest (Lipersonic Imagine®)	Day 0
Secondary	blood pressure	measure of blood pressure using sphygmomanometer	Day0
Secondary	blood pressure	measure of blood pressure using sphygmomanometer	month 3
Secondary	Fitness	6-minutes walking test to assess functional capacity at a sub-maximal level, and the effects of exercise training in cardiac and pulmonary patients.	Month 3
Secondary	Fitness	6-minutes walking test to assess functional capacity at a sub-maximal level, and the effects of exercise training in cardiac and pulmonary patients.	Day 0
Secondary	muscle mass	measure of muscle mass using impedancemeter	Month 3
Secondary	fat mass	measure of muscle mass using impedancemeter	Month 3
Secondary	bone structure	measure of muscle mass using impedancemeter	Month 3
Secondary	muscle mass	measure of muscle mass using impedancemeter	Day 0
Secondary	fat mass	measure of muscle mass using impedancemeter	Day 0
Secondary	bone structure	measure of muscle mass using impedancemeter	Day 0
Secondary	muscle mass	measure of muscle mass using Densitometry X-ray absorption	Day 0
Secondary	fat mass	measure of muscle mass using Densitometry X-ray absorption	Day 0
Secondary	bone structure	measure of muscle mass using Densitometry X-ray absorption	Day 0
Secondary	muscle mass	measure of muscle mass using Densitometry X-ray absorption	Month 3
Secondary	fat mass	measure of muscle mass using Densitometry X-ray absorption	Month 3
Secondary	bone structure	measure of muscle mass using Densitometry X-ray absorption	Month 3
Secondary	muscle mass	measure of muscle mass using Peripheral quantitative computed tomography (pQCT)	Month 3
Secondary	fat mass	measure of muscle mass using Peripheral quantitative computed tomography (pQCT)	Month 3
Secondary	bone structure	measure of muscle mass using Peripheral quantitative computed tomography (pQCT)	Month 3
Secondary	muscle mass	measure of muscle mass using Peripheral quantitative computed tomography (pQCT)	Day 0
Secondary	fat mass	measure of muscle mass using Peripheral quantitative computed tomography (pQCT)	Day 0
Secondary	bone structure	measure of muscle mass using Peripheral quantitative computed tomography (pQCT)	Day 0
Secondary	muscle mass	measure of muscle mass using Quantitative ultrasounds (QUS)	Day 0
Secondary	fat mass	measure of muscle mass using Quantitative ultrasounds (QUS)	Day 0
Secondary	bone structure	measure of muscle mass using Quantitative ultrasounds (QUS)	Day 0
Secondary	muscle mass	measure of muscle mass using Quantitative ultrasounds (QUS)	Month 3
Secondary	fat mass	measure of muscle mass using Quantitative ultrasounds (QUS)	Month 3
Secondary	bone structure	measure of muscle mass using Quantitative ultrasounds (QUS)	Month 3
Secondary	depression	depression is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always".	Day 0
Secondary	depression	depression is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always".	Month 3
Secondary	anxiety	anxiety is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always". It is also evaluated by the State-Trait Anxiety Inventory (STAI) composed by two dimensions, state anxiety and trait anxiety, both evaluated with a 20-items questionnaire on a 4-point scale from "never" to "always"	Day 0
Secondary	anxiety	anxiety is assessed by the Hospital Anxiety and Depression scale (HAD) composed by 7 items and a 4-point scale from "never" to "always". It is also evaluated by the State-Trait Anxiety Inventory (STAI) composed by two dimensions, state anxiety and trait anxiety, both evaluated with a 20-items questionnaire on a 4-point scale from "never" to "always"	Month 3
Secondary	General health	general health is assessed by the short form 36 health survey (SF36) composed by 36 items	Day 0
Secondary	General health	general health is assessed by the short form 36 health survey (SF36) composed by 36 items	Month 3
Secondary	Stress	stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)	day 0
Secondary	Stress	stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)	Month 3
Secondary	Fatigue	Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)	Day 0
Secondary	Fatigue	Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)	Month 3
Secondary	Sleep	Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".	day 0
Secondary	Sleep	Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".	Month 3
Secondary	Burnout	Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".	day 0
Secondary	Burnout	Burnout is assessed by the Maslach Burn-out Inventory (MBI) composed by 22 items and a 7-point scale ranging from "never" to "every day".	Month 3
Secondary	Mindfulness	Midfuless is assessed by the Freiburg Mindfulness Inventory-14 (FMI) composed by a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree)	Day 0
Secondary	Mindfulness	Midfuless is assessed by the Freiburg Mindfulness Inventory-14 (FMI) composed by a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree)	Month 3
Secondary	Coping	Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale	Day 0
Secondary	Coping	Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale	Month 3
Secondary	Emotions	Emotions are assessed by the Emotion Régulation Questionnaire (ERQ) composed by 10 items on a 7-point likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)	Day 0
Secondary	Emotions	Emotions are assessed by the Emotion Régulation Questionnaire (ERQ) composed by 10 items on a 7-point likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)	Month 3
Secondary	Perception of work	Work perception is assessed by the Job Demand-Control-Support (JDSC) questionnaire of Karasek composed by 26 items on a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). It is also evaluated by the effort-reward imbalance model (ERI) of Siegrist composed by 46 items on a 5-point scale ranging from 1 (no agreement) to 5 (agree and very disturb).	Day 0
Secondary	Perception of work	Work perception is assessed by the Job Demand-Control-Support (JDSC) questionnaire of Karasek composed by 26 items on a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). It is also evaluated by the effort-reward imbalance model (ERI) of Siegrist composed by 46 items on a 5-point scale ranging from 1 (no agreement) to 5 (agree and very disturb).	Month 3
Secondary	Self-efficacy	Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale	Day 0
Secondary	Self-efficacy	Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale	Month 3
Secondary	Alexithymia	Alexithymia is assessed by the Twenty-item Toronto Alexithymia Scale (TAS20) composed by a 5-point scale from "strongly agree" to "strongly disagree".	Day 0
Secondary	Alexithymia	Alexithymia is assessed by the Twenty-item Toronto Alexithymia Scale (TAS20) composed by a 5-point scale from "strongly agree" to "strongly disagree".	Month 3
Secondary	Illness perception	Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.	Day 0
Secondary	Illness perception	Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.	Month 3
Secondary	Metacognition	Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale	Day 0
Secondary	Metacognition	Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale	Month 3
Secondary	Time perception	Perception of the time is assessed by the Metacognitive questionnaire on time perception (MQT) composed by 24 items on a 5-point scale. It is also evaluated by the Zimbardo Time Perspective Inventory (ZPTI) composed by 56 items on a 5-point scale from "very uncharacteristic" to "very characteristic".	Day 0
Secondary	Time perception	Perception of the time is assessed by the Metacognitive questionnaire on time perception (MQT) composed by 24 items on a 5-point scale. It is also evaluated by the Zimbardo Time Perspective Inventory (ZPTI) composed by 56 items on a 5-point scale from "very uncharacteristic" to "very characteristic".	Month 3
Secondary	Physical activity	Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)	Day 0
Secondary	Physical activity	Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)	Month 3
Secondary	Life style	life style is assessed with a questionnaire on coffee consumption, food intake, etc	Day 0
Secondary	Life style	life style is assessed with a questionnaire on coffee consumption, food intake, etc	Month 3
Secondary	cholesterol	measure by blood analyses to evaluate alloplastic load	Day 0
Secondary	triglycerides	measure by blood analyses to evaluate alloplastic load	Day 0
Secondary	cholesterol	measure by blood analyses to evaluate alloplastic load	Month 3
Secondary	triglycerides	measure by blood analyses to evaluate alloplastic load	Month 3
Secondary	Cortisol	hormone measure by blood analyses to evaluate alloplastic load	Day 0
Secondary	Cortisol	hormone measure by blood analyses to evaluate alloplastic load	Month 3
Secondary	DHEAS	hormone measure by blood analyses to evaluate alloplastic load	day 0
Secondary	DHEAS	hormone measure by blood analyses to evaluate alloplastic load	Month 3
Secondary	BDNF	proteins measure by blood analyses to evaluate alloplastic load	Day 0
Secondary	BDNF	proteins measure by blood analyses to evaluate alloplastic load	Month 3
Secondary	CRP	proteins measure by blood analyses to evaluate alloplastic load	Day 0
Secondary	pro-inflammatory cytokines	proteins measure by blood analyses to evaluate alloplastic load	Day 0
Secondary	TNF alpha	proteins measure by blood analyses to evaluate alloplastic load	Day 0
Secondary	CRP	proteins measure by blood analyses to evaluate alloplastic load	Month 3
Secondary	pro-inflammatory cytokines	proteins measure by blood analyses to evaluate alloplastic load	Month 3
Secondary	TNF alpha	proteins measure by blood analyses to evaluate alloplastic load	Month 3
Secondary	NPY	proteins measure by blood analyses to evaluate alloplastic load	Month 3
Secondary	NPY	proteins measure by blood analyses to evaluate alloplastic load	Day 0
Secondary	Leptin	measure by blood analyses to evaluate appetite regulation	Day 0
Secondary	Leptin	measure by blood analyses to evaluate appetite regulation	Month 3
Secondary	Ghrelin	measure by blood analyses to evaluate appetite regulation	Day 0
Secondary	Ghrelin	measure by blood analyses to evaluate appetite regulation	Month 3
Secondary	NPY	measure by blood analyses to evaluate appetite regulation	day 0
Secondary	NPY	measure by blood analyses to evaluate appetite regulation	Month 3
Secondary	adiponectine	measure by blood analyses to evaluate appetite regulation	Day 0
Secondary	adiponectine	measure by blood analyses to evaluate appetite regulation	Month 3
Secondary	CCK	measure by blood analyses to evaluate appetite regulation	Day 0
Secondary	Month 3	measure by blood analyses to evaluate appetite regulation	Day 0
Secondary	Insulin	measure by blood analyses to evaluate glucid metabolism	Day 0
Secondary	Insulin	measure by blood analyses to evaluate glucid metabolism	Month 3
Secondary	HbA1c	measure by blood analyses to evaluate glucid metabolism	Day 0
Secondary	HbA1c	measure by blood analyses to evaluate glucid metabolism	Month 3
Secondary	glucose	measure by blood analyses to evaluate glucid metabolism	Day 0
Secondary	glucose	measure by blood analyses to evaluate glucid metabolism	Month 3
Secondary	Albumin	measure by blood analyses to evaluate protid metabolism	Day 0
Secondary	Albumin	measure by blood analyses to evaluate protid metabolism	Month 3
Secondary	transthyretin	measure by blood analyses to evaluate protid metabolism	Day 0
Secondary	transthyretin	measure by blood analyses to evaluate protid metabolism	Month 3
Secondary	Homeostasis	measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism	Day 0
Secondary	Homeostasis	measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism	Month 3
Secondary	Osteoresorption	measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism	Day 0
Secondary	Osteoresorption	measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism	Month 3
Secondary	Osteoformation	measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism	Day 0
Secondary	Osteoformation	measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism	Month 3
Secondary	VEGF	measure by blood analyses to evaluate cardiovascular function	Day 0
Secondary	VEGF	measure by blood analyses to evaluate cardiovascular function	Month 3
Secondary	PAI1	measure by blood analyses to evaluate cardiovascular function	Day 0
Secondary	PAI1	measure by blood analyses to evaluate cardiovascular function	Month 3
Secondary	weight	measure of weight in kilograms	Day 0
Secondary	weight	measure of weight in kilograms	Month 3
Secondary	waist circumference	measure of waist circumference in centimetres	Day 0
Secondary	waist circumference	measure of waist circumference in centimetres	Month 3