- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Clermont-Ferrand, Francia, 63000
- CHU de Clermont-Ferrand
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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. |
Sin intervención: Control group
to be normal-weighted (no obesity if overweight, <85th percentile of national curves).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
cardiac ectopic fat deposits
Periodo de tiempo: Month 3
|
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
|
Month 3
|
cardiac ectopic fat deposits
Periodo de tiempo: Day 0
|
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
|
Day 0
|
cardiac ectopic fat deposits
Periodo de tiempo: Day 0
|
Quantification of cardiac ectopic fat deposits (volume using MRI)
|
Day 0
|
cardiac ectopic fat deposits
Periodo de tiempo: Month 3
|
Quantification of cardiac ectopic fat deposits (volume using MRI)
|
Month 3
|
cardiac ectopic fat deposits
Periodo de tiempo: Month 3
|
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
|
Month 3
|
cardiac ectopic fat deposits
Periodo de tiempo: Day 0
|
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
|
Day 0
|
left myocardial regional function
Periodo de tiempo: Month 3
|
left myocardial regional function (echocardiography)
|
Month 3
|
left myocardial regional function
Periodo de tiempo: Month 3
|
left myocardial regional function (MRI)
|
Month 3
|
left myocardial regional function
Periodo de tiempo: Day 0
|
left myocardial regional function (echocardiography)
|
Day 0
|
left myocardial regional function
Periodo de tiempo: Day 0
|
left myocardial regional function (MRI)
|
Day 0
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
macrovascularisation
Periodo de tiempo: Day 0
|
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
|
Day 0
|
macrovascularisation
Periodo de tiempo: Month 3
|
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
|
Month 3
|
microvascularisation
Periodo de tiempo: Month 3
|
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
|
Month 3
|
microvascularisation
Periodo de tiempo: Day 0
|
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
|
Day 0
|
microvascularisation
Periodo de tiempo: Day 0
|
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
|
Day 0
|
microvascularisation
Periodo de tiempo: Month 3
|
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
|
Month 3
|
microvascularisation
Periodo de tiempo: Month 3
|
measure of microvascular perfusion using Iontophoresis procedure
|
Month 3
|
microvascularisation
Periodo de tiempo: Day 0
|
measure of microvascular perfusion using Iontophoresis procedure
|
Day 0
|
microvascularisation
Periodo de tiempo: Day 0
|
measure of microvascular perfusion using flowmotion
|
Day 0
|
microvascularisation
Periodo de tiempo: Month 3
|
measure of microvascular perfusion using flowmotion
|
Month 3
|
heart rate variability
Periodo de tiempo: Month 3
|
measure of heart rate variability using a holter
|
Month 3
|
heart rate variability
Periodo de tiempo: Day 0
|
measure of heart rate variability using a holter
|
Day 0
|
skin conductance
Periodo de tiempo: Day 0
|
measure of skin conductance using Wristband electrodes - Empatica E4
|
Day 0
|
skin conductance
Periodo de tiempo: Month 3
|
measure of skin conductance using Wristband electrodes - Empatica E4
|
Month 3
|
Liver steatosis
Periodo de tiempo: Month 3
|
measure of liver steatosis by MRI
|
Month 3
|
Liver steatosis
Periodo de tiempo: Day 0
|
measure of liver steatosis by MRI
|
Day 0
|
Liver steatosis
Periodo de tiempo: Day 0
|
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
|
Day 0
|
Liver steatosis
Periodo de tiempo: Month 3
|
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
|
Month 3
|
Liver steatosis
Periodo de tiempo: month 3
|
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
|
month 3
|
Liver steatosis
Periodo de tiempo: Day 0
|
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
|
Day 0
|
Liver fibrosis
Periodo de tiempo: Day 0
|
measure of liver fibrosis by fibroscanner (liver stiffness)
|
Day 0
|
Liver fibrosis
Periodo de tiempo: Month 3
|
measure of liver fibrosis by fibroscanner (liver stiffness)
|
Month 3
|
Liver fibrosis
Periodo de tiempo: Month 3
|
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
|
Month 3
|
Liver fibrosis
Periodo de tiempo: Day 0
|
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
|
Day 0
|
blood pressure
Periodo de tiempo: Day0
|
measure of blood pressure using sphygmomanometer
|
Day0
|
blood pressure
Periodo de tiempo: month 3
|
measure of blood pressure using sphygmomanometer
|
month 3
|
Fitness
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
fat mass
Periodo de tiempo: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
bone structure
Periodo de tiempo: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
muscle mass
Periodo de tiempo: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
fat mass
Periodo de tiempo: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
bone structure
Periodo de tiempo: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
muscle mass
Periodo de tiempo: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
fat mass
Periodo de tiempo: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
bone structure
Periodo de tiempo: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
muscle mass
Periodo de tiempo: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
fat mass
Periodo de tiempo: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
bone structure
Periodo de tiempo: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
muscle mass
Periodo de tiempo: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
fat mass
Periodo de tiempo: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
bone structure
Periodo de tiempo: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
muscle mass
Periodo de tiempo: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
fat mass
Periodo de tiempo: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
bone structure
Periodo de tiempo: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
muscle mass
Periodo de tiempo: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
fat mass
Periodo de tiempo: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
bone structure
Periodo de tiempo: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
muscle mass
Periodo de tiempo: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
fat mass
Periodo de tiempo: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
bone structure
Periodo de tiempo: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
depression
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 0
|
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
|
Day 0
|
General health
Periodo de tiempo: Month 3
|
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
|
Month 3
|
Stress
Periodo de tiempo: day 0
|
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
day 0
|
Stress
Periodo de tiempo: Month 3
|
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Month 3
|
Fatigue
Periodo de tiempo: Day 0
|
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Day 0
|
Fatigue
Periodo de tiempo: Month 3
|
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Month 3
|
Sleep
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 0
|
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
|
Day 0
|
Coping
Periodo de tiempo: Month 3
|
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
|
Month 3
|
Emotions
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Month 3
|
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
|
Month 3
|
Alexithymia
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Month 3
|
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
|
Month 3
|
Metacognition
Periodo de tiempo: Day 0
|
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
|
Day 0
|
Metacognition
Periodo de tiempo: Month 3
|
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
|
Month 3
|
Time perception
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 0
|
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
|
Day 0
|
Physical activity
Periodo de tiempo: Month 3
|
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
|
Month 3
|
Life style
Periodo de tiempo: Day 0
|
life style is assessed with a questionnaire on coffee consumption, food intake, etc
|
Day 0
|
Life style
Periodo de tiempo: Month 3
|
life style is assessed with a questionnaire on coffee consumption, food intake, etc
|
Month 3
|
cholesterol
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate alloplastic load
|
Day 0
|
triglycerides
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate alloplastic load
|
Day 0
|
cholesterol
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate alloplastic load
|
Month 3
|
triglycerides
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate alloplastic load
|
Month 3
|
Cortisol
Periodo de tiempo: Day 0
|
hormone measure by blood analyses to evaluate alloplastic load
|
Day 0
|
Cortisol
Periodo de tiempo: Month 3
|
hormone measure by blood analyses to evaluate alloplastic load
|
Month 3
|
DHEAS
Periodo de tiempo: day 0
|
hormone measure by blood analyses to evaluate alloplastic load
|
day 0
|
DHEAS
Periodo de tiempo: Month 3
|
hormone measure by blood analyses to evaluate alloplastic load
|
Month 3
|
BDNF
Periodo de tiempo: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
BDNF
Periodo de tiempo: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
CRP
Periodo de tiempo: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
pro-inflammatory cytokines
Periodo de tiempo: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
TNF alpha
Periodo de tiempo: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
CRP
Periodo de tiempo: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
pro-inflammatory cytokines
Periodo de tiempo: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
TNF alpha
Periodo de tiempo: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
NPY
Periodo de tiempo: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
NPY
Periodo de tiempo: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
Leptin
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Leptin
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
Ghrelin
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Ghrelin
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
NPY
Periodo de tiempo: day 0
|
measure by blood analyses to evaluate appetite regulation
|
day 0
|
NPY
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
adiponectine
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
adiponectine
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
CCK
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Month 3
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Insulin
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
Insulin
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
HbA1c
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
HbA1c
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
glucose
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
glucose
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
Albumin
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate protid metabolism
|
Day 0
|
Albumin
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate protid metabolism
|
Month 3
|
transthyretin
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate protid metabolism
|
Day 0
|
transthyretin
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate protid metabolism
|
Month 3
|
Homeostasis
Periodo de tiempo: Day 0
|
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
|
Day 0
|
Homeostasis
Periodo de tiempo: Month 3
|
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
|
Month 3
|
Osteoresorption
Periodo de tiempo: Day 0
|
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
|
Day 0
|
Osteoresorption
Periodo de tiempo: Month 3
|
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
|
Month 3
|
Osteoformation
Periodo de tiempo: Day 0
|
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
|
Day 0
|
Osteoformation
Periodo de tiempo: Month 3
|
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
|
Month 3
|
VEGF
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate cardiovascular function
|
Day 0
|
VEGF
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate cardiovascular function
|
Month 3
|
PAI1
Periodo de tiempo: Day 0
|
measure by blood analyses to evaluate cardiovascular function
|
Day 0
|
PAI1
Periodo de tiempo: Month 3
|
measure by blood analyses to evaluate cardiovascular function
|
Month 3
|
weight
Periodo de tiempo: Day 0
|
measure of weight in kilograms
|
Day 0
|
weight
Periodo de tiempo: Month 3
|
measure of weight in kilograms
|
Month 3
|
waist circumference
Periodo de tiempo: Day 0
|
measure of waist circumference in centimetres
|
Day 0
|
waist circumference
Periodo de tiempo: Month 3
|
measure of waist circumference in centimetres
|
Month 3
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RBHP 2019 DUTHEIL
- 2019-A01804-53 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .