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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Clermont-Ferrand、フランス、63000
- CHU de Clermont-Ferrand
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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. |
介入なし:Control group
to be normal-weighted (no obesity if overweight, <85th percentile of national curves).
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
cardiac ectopic fat deposits
時間枠:Month 3
|
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
|
Month 3
|
cardiac ectopic fat deposits
時間枠:Day 0
|
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
|
Day 0
|
cardiac ectopic fat deposits
時間枠:Day 0
|
Quantification of cardiac ectopic fat deposits (volume using MRI)
|
Day 0
|
cardiac ectopic fat deposits
時間枠:Month 3
|
Quantification of cardiac ectopic fat deposits (volume using MRI)
|
Month 3
|
cardiac ectopic fat deposits
時間枠:Month 3
|
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
|
Month 3
|
cardiac ectopic fat deposits
時間枠:Day 0
|
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
|
Day 0
|
left myocardial regional function
時間枠:Month 3
|
left myocardial regional function (echocardiography)
|
Month 3
|
left myocardial regional function
時間枠:Month 3
|
left myocardial regional function (MRI)
|
Month 3
|
left myocardial regional function
時間枠:Day 0
|
left myocardial regional function (echocardiography)
|
Day 0
|
left myocardial regional function
時間枠:Day 0
|
left myocardial regional function (MRI)
|
Day 0
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
macrovascularisation
時間枠:Day 0
|
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
|
Day 0
|
macrovascularisation
時間枠:Month 3
|
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
|
Month 3
|
microvascularisation
時間枠:Month 3
|
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
|
Month 3
|
microvascularisation
時間枠:Day 0
|
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
|
Day 0
|
microvascularisation
時間枠:Day 0
|
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
|
Day 0
|
microvascularisation
時間枠:Month 3
|
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
|
Month 3
|
microvascularisation
時間枠:Month 3
|
measure of microvascular perfusion using Iontophoresis procedure
|
Month 3
|
microvascularisation
時間枠:Day 0
|
measure of microvascular perfusion using Iontophoresis procedure
|
Day 0
|
microvascularisation
時間枠:Day 0
|
measure of microvascular perfusion using flowmotion
|
Day 0
|
microvascularisation
時間枠:Month 3
|
measure of microvascular perfusion using flowmotion
|
Month 3
|
heart rate variability
時間枠:Month 3
|
measure of heart rate variability using a holter
|
Month 3
|
heart rate variability
時間枠:Day 0
|
measure of heart rate variability using a holter
|
Day 0
|
skin conductance
時間枠:Day 0
|
measure of skin conductance using Wristband electrodes - Empatica E4
|
Day 0
|
skin conductance
時間枠:Month 3
|
measure of skin conductance using Wristband electrodes - Empatica E4
|
Month 3
|
Liver steatosis
時間枠:Month 3
|
measure of liver steatosis by MRI
|
Month 3
|
Liver steatosis
時間枠:Day 0
|
measure of liver steatosis by MRI
|
Day 0
|
Liver steatosis
時間枠:Day 0
|
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
|
Day 0
|
Liver steatosis
時間枠:Month 3
|
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
|
Month 3
|
Liver steatosis
時間枠:month 3
|
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
|
month 3
|
Liver steatosis
時間枠:Day 0
|
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
|
Day 0
|
Liver fibrosis
時間枠:Day 0
|
measure of liver fibrosis by fibroscanner (liver stiffness)
|
Day 0
|
Liver fibrosis
時間枠:Month 3
|
measure of liver fibrosis by fibroscanner (liver stiffness)
|
Month 3
|
Liver fibrosis
時間枠:Month 3
|
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
|
Month 3
|
Liver fibrosis
時間枠:Day 0
|
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
|
Day 0
|
blood pressure
時間枠:Day0
|
measure of blood pressure using sphygmomanometer
|
Day0
|
blood pressure
時間枠:month 3
|
measure of blood pressure using sphygmomanometer
|
month 3
|
Fitness
時間枠: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
時間枠: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
時間枠:Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
fat mass
時間枠:Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
bone structure
時間枠:Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
muscle mass
時間枠:Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
fat mass
時間枠:Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
bone structure
時間枠:Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
muscle mass
時間枠:Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
fat mass
時間枠:Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
bone structure
時間枠:Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
muscle mass
時間枠:Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
fat mass
時間枠:Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
bone structure
時間枠:Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
muscle mass
時間枠:Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
fat mass
時間枠:Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
bone structure
時間枠:Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
muscle mass
時間枠:Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
fat mass
時間枠:Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
bone structure
時間枠:Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
muscle mass
時間枠:Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
fat mass
時間枠:Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
bone structure
時間枠:Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
muscle mass
時間枠:Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
fat mass
時間枠:Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
bone structure
時間枠:Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
depression
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Day 0
|
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
|
Day 0
|
General health
時間枠:Month 3
|
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
|
Month 3
|
Stress
時間枠:day 0
|
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
day 0
|
Stress
時間枠:Month 3
|
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Month 3
|
Fatigue
時間枠:Day 0
|
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Day 0
|
Fatigue
時間枠:Month 3
|
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Month 3
|
Sleep
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Day 0
|
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
|
Day 0
|
Coping
時間枠:Month 3
|
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
|
Month 3
|
Emotions
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Month 3
|
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
|
Month 3
|
Alexithymia
時間枠: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
時間枠: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
時間枠: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
時間枠:Month 3
|
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
|
Month 3
|
Metacognition
時間枠:Day 0
|
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
|
Day 0
|
Metacognition
時間枠:Month 3
|
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
|
Month 3
|
Time perception
時間枠: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
時間枠: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
時間枠:Day 0
|
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
|
Day 0
|
Physical activity
時間枠:Month 3
|
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
|
Month 3
|
Life style
時間枠:Day 0
|
life style is assessed with a questionnaire on coffee consumption, food intake, etc
|
Day 0
|
Life style
時間枠:Month 3
|
life style is assessed with a questionnaire on coffee consumption, food intake, etc
|
Month 3
|
cholesterol
時間枠:Day 0
|
measure by blood analyses to evaluate alloplastic load
|
Day 0
|
triglycerides
時間枠:Day 0
|
measure by blood analyses to evaluate alloplastic load
|
Day 0
|
cholesterol
時間枠:Month 3
|
measure by blood analyses to evaluate alloplastic load
|
Month 3
|
triglycerides
時間枠:Month 3
|
measure by blood analyses to evaluate alloplastic load
|
Month 3
|
Cortisol
時間枠:Day 0
|
hormone measure by blood analyses to evaluate alloplastic load
|
Day 0
|
Cortisol
時間枠:Month 3
|
hormone measure by blood analyses to evaluate alloplastic load
|
Month 3
|
DHEAS
時間枠:day 0
|
hormone measure by blood analyses to evaluate alloplastic load
|
day 0
|
DHEAS
時間枠:Month 3
|
hormone measure by blood analyses to evaluate alloplastic load
|
Month 3
|
BDNF
時間枠:Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
BDNF
時間枠:Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
CRP
時間枠:Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
pro-inflammatory cytokines
時間枠:Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
TNF alpha
時間枠:Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
CRP
時間枠:Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
pro-inflammatory cytokines
時間枠:Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
TNF alpha
時間枠:Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
NPY
時間枠:Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
NPY
時間枠:Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
Leptin
時間枠:Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Leptin
時間枠:Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
Ghrelin
時間枠:Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Ghrelin
時間枠:Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
NPY
時間枠:day 0
|
measure by blood analyses to evaluate appetite regulation
|
day 0
|
NPY
時間枠:Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
adiponectine
時間枠:Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
adiponectine
時間枠:Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
CCK
時間枠:Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Month 3
時間枠:Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Insulin
時間枠:Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
Insulin
時間枠:Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
HbA1c
時間枠:Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
HbA1c
時間枠:Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
glucose
時間枠:Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
glucose
時間枠:Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
Albumin
時間枠:Day 0
|
measure by blood analyses to evaluate protid metabolism
|
Day 0
|
Albumin
時間枠:Month 3
|
measure by blood analyses to evaluate protid metabolism
|
Month 3
|
transthyretin
時間枠:Day 0
|
measure by blood analyses to evaluate protid metabolism
|
Day 0
|
transthyretin
時間枠:Month 3
|
measure by blood analyses to evaluate protid metabolism
|
Month 3
|
Homeostasis
時間枠:Day 0
|
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
|
Day 0
|
Homeostasis
時間枠:Month 3
|
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
|
Month 3
|
Osteoresorption
時間枠:Day 0
|
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
|
Day 0
|
Osteoresorption
時間枠:Month 3
|
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
|
Month 3
|
Osteoformation
時間枠:Day 0
|
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
|
Day 0
|
Osteoformation
時間枠:Month 3
|
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
|
Month 3
|
VEGF
時間枠:Day 0
|
measure by blood analyses to evaluate cardiovascular function
|
Day 0
|
VEGF
時間枠:Month 3
|
measure by blood analyses to evaluate cardiovascular function
|
Month 3
|
PAI1
時間枠:Day 0
|
measure by blood analyses to evaluate cardiovascular function
|
Day 0
|
PAI1
時間枠:Month 3
|
measure by blood analyses to evaluate cardiovascular function
|
Month 3
|
weight
時間枠:Day 0
|
measure of weight in kilograms
|
Day 0
|
weight
時間枠:Month 3
|
measure of weight in kilograms
|
Month 3
|
waist circumference
時間枠:Day 0
|
measure of waist circumference in centimetres
|
Day 0
|
waist circumference
時間枠:Month 3
|
measure of waist circumference in centimetres
|
Month 3
|
協力者と研究者
協力者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- RBHP 2019 DUTHEIL
- 2019-A01804-53 (その他の識別子:ANSM)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。