- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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) (CARDIBOX)
Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Clermont-Ferrand, France, 63000
- CHU de Clermont-Ferrand
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Obese adolescents
BMI greater than the 97th percentile of national curves.
Participants will follow a 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. |
Aucune intervention: Control group
to be normal-weighted (no obesity if overweight, <85th percentile of national curves).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
cardiac ectopic fat deposits
Délai: Month 3
|
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
|
Month 3
|
cardiac ectopic fat deposits
Délai: Day 0
|
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
|
Day 0
|
cardiac ectopic fat deposits
Délai: Day 0
|
Quantification of cardiac ectopic fat deposits (volume using MRI)
|
Day 0
|
cardiac ectopic fat deposits
Délai: Month 3
|
Quantification of cardiac ectopic fat deposits (volume using MRI)
|
Month 3
|
cardiac ectopic fat deposits
Délai: Month 3
|
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
|
Month 3
|
cardiac ectopic fat deposits
Délai: Day 0
|
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
|
Day 0
|
left myocardial regional function
Délai: Month 3
|
left myocardial regional function (echocardiography)
|
Month 3
|
left myocardial regional function
Délai: Month 3
|
left myocardial regional function (MRI)
|
Month 3
|
left myocardial regional function
Délai: Day 0
|
left myocardial regional function (echocardiography)
|
Day 0
|
left myocardial regional function
Délai: Day 0
|
left myocardial regional function (MRI)
|
Day 0
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
macrovascularisation
Délai: Day 0
|
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
|
Day 0
|
macrovascularisation
Délai: Month 3
|
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
|
Month 3
|
microvascularisation
Délai: Month 3
|
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
|
Month 3
|
microvascularisation
Délai: Day 0
|
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
|
Day 0
|
microvascularisation
Délai: Day 0
|
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
|
Day 0
|
microvascularisation
Délai: Month 3
|
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
|
Month 3
|
microvascularisation
Délai: Month 3
|
measure of microvascular perfusion using Iontophoresis procedure
|
Month 3
|
microvascularisation
Délai: Day 0
|
measure of microvascular perfusion using Iontophoresis procedure
|
Day 0
|
microvascularisation
Délai: Day 0
|
measure of microvascular perfusion using flowmotion
|
Day 0
|
microvascularisation
Délai: Month 3
|
measure of microvascular perfusion using flowmotion
|
Month 3
|
heart rate variability
Délai: Month 3
|
measure of heart rate variability using a holter
|
Month 3
|
heart rate variability
Délai: Day 0
|
measure of heart rate variability using a holter
|
Day 0
|
skin conductance
Délai: Day 0
|
measure of skin conductance using Wristband electrodes - Empatica E4
|
Day 0
|
skin conductance
Délai: Month 3
|
measure of skin conductance using Wristband electrodes - Empatica E4
|
Month 3
|
Liver steatosis
Délai: Month 3
|
measure of liver steatosis by MRI
|
Month 3
|
Liver steatosis
Délai: Day 0
|
measure of liver steatosis by MRI
|
Day 0
|
Liver steatosis
Délai: Day 0
|
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
|
Day 0
|
Liver steatosis
Délai: Month 3
|
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
|
Month 3
|
Liver steatosis
Délai: month 3
|
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
|
month 3
|
Liver steatosis
Délai: Day 0
|
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
|
Day 0
|
Liver fibrosis
Délai: Day 0
|
measure of liver fibrosis by fibroscanner (liver stiffness)
|
Day 0
|
Liver fibrosis
Délai: Month 3
|
measure of liver fibrosis by fibroscanner (liver stiffness)
|
Month 3
|
Liver fibrosis
Délai: Month 3
|
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
|
Month 3
|
Liver fibrosis
Délai: Day 0
|
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
|
Day 0
|
blood pressure
Délai: Day0
|
measure of blood pressure using sphygmomanometer
|
Day0
|
blood pressure
Délai: month 3
|
measure of blood pressure using sphygmomanometer
|
month 3
|
Fitness
Délai: Month 3
|
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
|
Fitness
Délai: Day 0
|
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
|
muscle mass
Délai: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
fat mass
Délai: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
bone structure
Délai: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
muscle mass
Délai: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
fat mass
Délai: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
bone structure
Délai: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
muscle mass
Délai: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
fat mass
Délai: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
bone structure
Délai: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
muscle mass
Délai: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
fat mass
Délai: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
bone structure
Délai: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
muscle mass
Délai: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
fat mass
Délai: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
bone structure
Délai: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
muscle mass
Délai: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
fat mass
Délai: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
bone structure
Délai: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
muscle mass
Délai: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
fat mass
Délai: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
bone structure
Délai: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
muscle mass
Délai: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
fat mass
Délai: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
bone structure
Délai: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
depression
Délai: Day 0
|
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
|
depression
Délai: Month 3
|
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
|
anxiety
Délai: Day 0
|
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
|
anxiety
Délai: Month 3
|
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
|
General health
Délai: Day 0
|
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
|
Day 0
|
General health
Délai: Month 3
|
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
|
Month 3
|
Stress
Délai: day 0
|
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
day 0
|
Stress
Délai: Month 3
|
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Month 3
|
Fatigue
Délai: Day 0
|
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Day 0
|
Fatigue
Délai: Month 3
|
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Month 3
|
Sleep
Délai: day 0
|
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
|
Sleep
Délai: Month 3
|
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
|
Burnout
Délai: day 0
|
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
|
Burnout
Délai: Month 3
|
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
|
Mindfulness
Délai: Day 0
|
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
|
Mindfulness
Délai: Month 3
|
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
|
Coping
Délai: Day 0
|
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
|
Day 0
|
Coping
Délai: Month 3
|
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
|
Month 3
|
Emotions
Délai: Day 0
|
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
|
Emotions
Délai: Month 3
|
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
|
Perception of work
Délai: Day 0
|
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
|
Perception of work
Délai: Month 3
|
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
|
Self-efficacy
Délai: Day 0
|
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
|
Day 0
|
Self-efficacy
Délai: Month 3
|
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
|
Month 3
|
Alexithymia
Délai: Day 0
|
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
|
Alexithymia
Délai: Month 3
|
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
|
Illness perception
Délai: Day 0
|
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
|
Day 0
|
Illness perception
Délai: Month 3
|
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
|
Month 3
|
Metacognition
Délai: Day 0
|
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
|
Day 0
|
Metacognition
Délai: Month 3
|
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
|
Month 3
|
Time perception
Délai: Day 0
|
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
|
Time perception
Délai: Month 3
|
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
|
Physical activity
Délai: Day 0
|
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
|
Day 0
|
Physical activity
Délai: Month 3
|
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
|
Month 3
|
Life style
Délai: Day 0
|
life style is assessed with a questionnaire on coffee consumption, food intake, etc
|
Day 0
|
Life style
Délai: Month 3
|
life style is assessed with a questionnaire on coffee consumption, food intake, etc
|
Month 3
|
cholesterol
Délai: Day 0
|
measure by blood analyses to evaluate alloplastic load
|
Day 0
|
triglycerides
Délai: Day 0
|
measure by blood analyses to evaluate alloplastic load
|
Day 0
|
cholesterol
Délai: Month 3
|
measure by blood analyses to evaluate alloplastic load
|
Month 3
|
triglycerides
Délai: Month 3
|
measure by blood analyses to evaluate alloplastic load
|
Month 3
|
Cortisol
Délai: Day 0
|
hormone measure by blood analyses to evaluate alloplastic load
|
Day 0
|
Cortisol
Délai: Month 3
|
hormone measure by blood analyses to evaluate alloplastic load
|
Month 3
|
DHEAS
Délai: day 0
|
hormone measure by blood analyses to evaluate alloplastic load
|
day 0
|
DHEAS
Délai: Month 3
|
hormone measure by blood analyses to evaluate alloplastic load
|
Month 3
|
BDNF
Délai: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
BDNF
Délai: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
CRP
Délai: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
pro-inflammatory cytokines
Délai: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
TNF alpha
Délai: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
CRP
Délai: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
pro-inflammatory cytokines
Délai: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
TNF alpha
Délai: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
NPY
Délai: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
NPY
Délai: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
Leptin
Délai: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Leptin
Délai: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
Ghrelin
Délai: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Ghrelin
Délai: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
NPY
Délai: day 0
|
measure by blood analyses to evaluate appetite regulation
|
day 0
|
NPY
Délai: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
adiponectine
Délai: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
adiponectine
Délai: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
CCK
Délai: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Month 3
Délai: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Insulin
Délai: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
Insulin
Délai: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
HbA1c
Délai: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
HbA1c
Délai: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
glucose
Délai: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
glucose
Délai: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
Albumin
Délai: Day 0
|
measure by blood analyses to evaluate protid metabolism
|
Day 0
|
Albumin
Délai: Month 3
|
measure by blood analyses to evaluate protid metabolism
|
Month 3
|
transthyretin
Délai: Day 0
|
measure by blood analyses to evaluate protid metabolism
|
Day 0
|
transthyretin
Délai: Month 3
|
measure by blood analyses to evaluate protid metabolism
|
Month 3
|
Homeostasis
Délai: Day 0
|
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
|
Day 0
|
Homeostasis
Délai: Month 3
|
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
|
Month 3
|
Osteoresorption
Délai: Day 0
|
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
|
Day 0
|
Osteoresorption
Délai: Month 3
|
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
|
Month 3
|
Osteoformation
Délai: Day 0
|
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
|
Day 0
|
Osteoformation
Délai: Month 3
|
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
|
Month 3
|
VEGF
Délai: Day 0
|
measure by blood analyses to evaluate cardiovascular function
|
Day 0
|
VEGF
Délai: Month 3
|
measure by blood analyses to evaluate cardiovascular function
|
Month 3
|
PAI1
Délai: Day 0
|
measure by blood analyses to evaluate cardiovascular function
|
Day 0
|
PAI1
Délai: Month 3
|
measure by blood analyses to evaluate cardiovascular function
|
Month 3
|
weight
Délai: Day 0
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measure of weight in kilograms
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Day 0
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weight
Délai: Month 3
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measure of weight in kilograms
|
Month 3
|
waist circumference
Délai: Day 0
|
measure of waist circumference in centimetres
|
Day 0
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waist circumference
Délai: Month 3
|
measure of waist circumference in centimetres
|
Month 3
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RBHP 2019 DUTHEIL
- 2019-A01804-53 (Autre identifiant: ANSM)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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