- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Clermont-Ferrand, Francie, 63000
- CHU de Clermont-Ferrand
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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. |
Žádný zásah: Control group
to be normal-weighted (no obesity if overweight, <85th percentile of national curves).
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
cardiac ectopic fat deposits
Časové okno: Month 3
|
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
|
Month 3
|
cardiac ectopic fat deposits
Časové okno: Day 0
|
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
|
Day 0
|
cardiac ectopic fat deposits
Časové okno: Day 0
|
Quantification of cardiac ectopic fat deposits (volume using MRI)
|
Day 0
|
cardiac ectopic fat deposits
Časové okno: Month 3
|
Quantification of cardiac ectopic fat deposits (volume using MRI)
|
Month 3
|
cardiac ectopic fat deposits
Časové okno: Month 3
|
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
|
Month 3
|
cardiac ectopic fat deposits
Časové okno: Day 0
|
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
|
Day 0
|
left myocardial regional function
Časové okno: Month 3
|
left myocardial regional function (echocardiography)
|
Month 3
|
left myocardial regional function
Časové okno: Month 3
|
left myocardial regional function (MRI)
|
Month 3
|
left myocardial regional function
Časové okno: Day 0
|
left myocardial regional function (echocardiography)
|
Day 0
|
left myocardial regional function
Časové okno: Day 0
|
left myocardial regional function (MRI)
|
Day 0
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
macrovascularisation
Časové okno: Day 0
|
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
|
Day 0
|
macrovascularisation
Časové okno: Month 3
|
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
|
Month 3
|
microvascularisation
Časové okno: Month 3
|
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
|
Month 3
|
microvascularisation
Časové okno: Day 0
|
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
|
Day 0
|
microvascularisation
Časové okno: Day 0
|
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
|
Day 0
|
microvascularisation
Časové okno: Month 3
|
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
|
Month 3
|
microvascularisation
Časové okno: Month 3
|
measure of microvascular perfusion using Iontophoresis procedure
|
Month 3
|
microvascularisation
Časové okno: Day 0
|
measure of microvascular perfusion using Iontophoresis procedure
|
Day 0
|
microvascularisation
Časové okno: Day 0
|
measure of microvascular perfusion using flowmotion
|
Day 0
|
microvascularisation
Časové okno: Month 3
|
measure of microvascular perfusion using flowmotion
|
Month 3
|
heart rate variability
Časové okno: Month 3
|
measure of heart rate variability using a holter
|
Month 3
|
heart rate variability
Časové okno: Day 0
|
measure of heart rate variability using a holter
|
Day 0
|
skin conductance
Časové okno: Day 0
|
measure of skin conductance using Wristband electrodes - Empatica E4
|
Day 0
|
skin conductance
Časové okno: Month 3
|
measure of skin conductance using Wristband electrodes - Empatica E4
|
Month 3
|
Liver steatosis
Časové okno: Month 3
|
measure of liver steatosis by MRI
|
Month 3
|
Liver steatosis
Časové okno: Day 0
|
measure of liver steatosis by MRI
|
Day 0
|
Liver steatosis
Časové okno: Day 0
|
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
|
Day 0
|
Liver steatosis
Časové okno: Month 3
|
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
|
Month 3
|
Liver steatosis
Časové okno: month 3
|
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
|
month 3
|
Liver steatosis
Časové okno: Day 0
|
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
|
Day 0
|
Liver fibrosis
Časové okno: Day 0
|
measure of liver fibrosis by fibroscanner (liver stiffness)
|
Day 0
|
Liver fibrosis
Časové okno: Month 3
|
measure of liver fibrosis by fibroscanner (liver stiffness)
|
Month 3
|
Liver fibrosis
Časové okno: Month 3
|
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
|
Month 3
|
Liver fibrosis
Časové okno: Day 0
|
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
|
Day 0
|
blood pressure
Časové okno: Day0
|
measure of blood pressure using sphygmomanometer
|
Day0
|
blood pressure
Časové okno: month 3
|
measure of blood pressure using sphygmomanometer
|
month 3
|
Fitness
Časové okno: 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
Časové okno: 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
Časové okno: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
fat mass
Časové okno: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
bone structure
Časové okno: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
muscle mass
Časové okno: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
fat mass
Časové okno: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
bone structure
Časové okno: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
muscle mass
Časové okno: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
fat mass
Časové okno: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
bone structure
Časové okno: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
muscle mass
Časové okno: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
fat mass
Časové okno: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
bone structure
Časové okno: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
muscle mass
Časové okno: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
fat mass
Časové okno: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
bone structure
Časové okno: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
muscle mass
Časové okno: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
fat mass
Časové okno: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
bone structure
Časové okno: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
muscle mass
Časové okno: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
fat mass
Časové okno: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
bone structure
Časové okno: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
muscle mass
Časové okno: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
fat mass
Časové okno: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
bone structure
Časové okno: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
depression
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day 0
|
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
|
Day 0
|
General health
Časové okno: Month 3
|
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
|
Month 3
|
Stress
Časové okno: day 0
|
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
day 0
|
Stress
Časové okno: Month 3
|
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Month 3
|
Fatigue
Časové okno: Day 0
|
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Day 0
|
Fatigue
Časové okno: Month 3
|
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Month 3
|
Sleep
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day 0
|
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
|
Day 0
|
Coping
Časové okno: Month 3
|
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
|
Month 3
|
Emotions
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Month 3
|
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
|
Month 3
|
Alexithymia
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Month 3
|
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
|
Month 3
|
Metacognition
Časové okno: Day 0
|
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
|
Day 0
|
Metacognition
Časové okno: Month 3
|
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
|
Month 3
|
Time perception
Časové okno: 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
Časové okno: 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
Časové okno: Day 0
|
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
|
Day 0
|
Physical activity
Časové okno: Month 3
|
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
|
Month 3
|
Life style
Časové okno: Day 0
|
life style is assessed with a questionnaire on coffee consumption, food intake, etc
|
Day 0
|
Life style
Časové okno: Month 3
|
life style is assessed with a questionnaire on coffee consumption, food intake, etc
|
Month 3
|
cholesterol
Časové okno: Day 0
|
measure by blood analyses to evaluate alloplastic load
|
Day 0
|
triglycerides
Časové okno: Day 0
|
measure by blood analyses to evaluate alloplastic load
|
Day 0
|
cholesterol
Časové okno: Month 3
|
measure by blood analyses to evaluate alloplastic load
|
Month 3
|
triglycerides
Časové okno: Month 3
|
measure by blood analyses to evaluate alloplastic load
|
Month 3
|
Cortisol
Časové okno: Day 0
|
hormone measure by blood analyses to evaluate alloplastic load
|
Day 0
|
Cortisol
Časové okno: Month 3
|
hormone measure by blood analyses to evaluate alloplastic load
|
Month 3
|
DHEAS
Časové okno: day 0
|
hormone measure by blood analyses to evaluate alloplastic load
|
day 0
|
DHEAS
Časové okno: Month 3
|
hormone measure by blood analyses to evaluate alloplastic load
|
Month 3
|
BDNF
Časové okno: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
BDNF
Časové okno: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
CRP
Časové okno: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
pro-inflammatory cytokines
Časové okno: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
TNF alpha
Časové okno: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
CRP
Časové okno: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
pro-inflammatory cytokines
Časové okno: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
TNF alpha
Časové okno: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
NPY
Časové okno: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
NPY
Časové okno: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
Leptin
Časové okno: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Leptin
Časové okno: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
Ghrelin
Časové okno: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Ghrelin
Časové okno: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
NPY
Časové okno: day 0
|
measure by blood analyses to evaluate appetite regulation
|
day 0
|
NPY
Časové okno: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
adiponectine
Časové okno: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
adiponectine
Časové okno: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
CCK
Časové okno: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Month 3
Časové okno: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
Insulin
Časové okno: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
Insulin
Časové okno: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
HbA1c
Časové okno: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
HbA1c
Časové okno: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
glucose
Časové okno: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
glucose
Časové okno: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
Albumin
Časové okno: Day 0
|
measure by blood analyses to evaluate protid metabolism
|
Day 0
|
Albumin
Časové okno: Month 3
|
measure by blood analyses to evaluate protid metabolism
|
Month 3
|
transthyretin
Časové okno: Day 0
|
measure by blood analyses to evaluate protid metabolism
|
Day 0
|
transthyretin
Časové okno: Month 3
|
measure by blood analyses to evaluate protid metabolism
|
Month 3
|
Homeostasis
Časové okno: Day 0
|
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
|
Day 0
|
Homeostasis
Časové okno: Month 3
|
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
|
Month 3
|
Osteoresorption
Časové okno: Day 0
|
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
|
Day 0
|
Osteoresorption
Časové okno: Month 3
|
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
|
Month 3
|
Osteoformation
Časové okno: Day 0
|
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
|
Day 0
|
Osteoformation
Časové okno: Month 3
|
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
|
Month 3
|
VEGF
Časové okno: Day 0
|
measure by blood analyses to evaluate cardiovascular function
|
Day 0
|
VEGF
Časové okno: Month 3
|
measure by blood analyses to evaluate cardiovascular function
|
Month 3
|
PAI1
Časové okno: Day 0
|
measure by blood analyses to evaluate cardiovascular function
|
Day 0
|
PAI1
Časové okno: Month 3
|
measure by blood analyses to evaluate cardiovascular function
|
Month 3
|
weight
Časové okno: Day 0
|
measure of weight in kilograms
|
Day 0
|
weight
Časové okno: Month 3
|
measure of weight in kilograms
|
Month 3
|
waist circumference
Časové okno: Day 0
|
measure of waist circumference in centimetres
|
Day 0
|
waist circumference
Časové okno: Month 3
|
measure of waist circumference in centimetres
|
Month 3
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RBHP 2019 DUTHEIL
- 2019-A01804-53 (Jiný identifikátor: ANSM)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na 3-month lifestyle intervention
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AbbVie (prior sponsor, Abbott)DokončenoCentrální předčasná puberta (CPP) | Předčasný | Leuprolid acetát | Luteinizační hormon (LH) | Agonista hormonu uvolňujícího gonadotropiny (GnRHa) | Tanner Staging | Depotní formulace | Potlačení LH | Hormon uvolňující gonadotropin (GnRH) | Lupron | GnRH analog | Pediatrie centrální předčasná pubertaSpojené státy, Portoriko
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KK Women's and Children's HospitalNeznámýEmoční pohoda prvorodiček | Nutriční zdraví matky a dítěte | Rodičovská sebeúčinnost pro prvorodičky | Zkušenosti prvorodičekSingapur
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Washington University School of MedicineNational Heart, Lung, and Blood Institute (NHLBI)DokončenoHypertenze | Nadváha | Dyslipidemie | Prediabetický stav | Metabolický syndrom XSpojené státy