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)
2020년 3월 13일 업데이트: University Hospital, Clermont-Ferrand
Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise
The high prevalence of childhood obesity is a major public health issue, worldwide.
Childhood obesity is associated with a high risk of cardiovascular events in adulthood, but recent studies also point out the development of cardiovascular complications in childhood or adolescence justifying the need for early detection and appropriate therapeutic management to prevent the development of more severe abnormalities.
This project proposes to evaluate the myocardial function in a fine and comprehensive way (longitudinal, circumferential and radial linear deformations, and rotation / torsion mechanics) from the deformation imaging (MRI and high-resolution echocardiography), in obese adolescents following a lifestyle intervention combining diet and physical activity.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
50
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Clermont-Ferrand, 프랑스, 63000
- Chu de Clermont-Ferrand
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
12년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
간섭 없음: Control group
to be normal-weighted (no obesity if overweight, <85th percentile of national curves).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
cardiac ectopic fat deposits
기간: Month 3
|
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
|
Month 3
|
|
cardiac ectopic fat deposits
기간: Day 0
|
Quantification of cardiac ectopic fat deposits (thickness using echocardiography)
|
Day 0
|
|
cardiac ectopic fat deposits
기간: Day 0
|
Quantification of cardiac ectopic fat deposits (volume using MRI)
|
Day 0
|
|
cardiac ectopic fat deposits
기간: Month 3
|
Quantification of cardiac ectopic fat deposits (volume using MRI)
|
Month 3
|
|
cardiac ectopic fat deposits
기간: Month 3
|
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
|
Month 3
|
|
cardiac ectopic fat deposits
기간: Day 0
|
Quantification of cardiac ectopic fat deposits (myocardial triglyceride content evaluated by MRI)
|
Day 0
|
|
left myocardial regional function
기간: Month 3
|
left myocardial regional function (echocardiography)
|
Month 3
|
|
left myocardial regional function
기간: Month 3
|
left myocardial regional function (MRI)
|
Month 3
|
|
left myocardial regional function
기간: Day 0
|
left myocardial regional function (echocardiography)
|
Day 0
|
|
left myocardial regional function
기간: Day 0
|
left myocardial regional function (MRI)
|
Day 0
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
macrovascularisation
기간: Day 0
|
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
|
Day 0
|
|
macrovascularisation
기간: Month 3
|
measure of carotid intima-media thickness (CIMT) using High-resolution B-mode ultrasound
|
Month 3
|
|
microvascularisation
기간: Month 3
|
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
|
Month 3
|
|
microvascularisation
기간: Day 0
|
measure of blood flow velocity using laser speckle contrast imaging (LSCI)
|
Day 0
|
|
microvascularisation
기간: Day 0
|
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
|
Day 0
|
|
microvascularisation
기간: Month 3
|
measure of microvascular perfusion using laser-Doppler flowmetry (LDF)
|
Month 3
|
|
microvascularisation
기간: Month 3
|
measure of microvascular perfusion using Iontophoresis procedure
|
Month 3
|
|
microvascularisation
기간: Day 0
|
measure of microvascular perfusion using Iontophoresis procedure
|
Day 0
|
|
microvascularisation
기간: Day 0
|
measure of microvascular perfusion using flowmotion
|
Day 0
|
|
microvascularisation
기간: Month 3
|
measure of microvascular perfusion using flowmotion
|
Month 3
|
|
heart rate variability
기간: Month 3
|
measure of heart rate variability using a holter
|
Month 3
|
|
heart rate variability
기간: Day 0
|
measure of heart rate variability using a holter
|
Day 0
|
|
skin conductance
기간: Day 0
|
measure of skin conductance using Wristband electrodes - Empatica E4
|
Day 0
|
|
skin conductance
기간: Month 3
|
measure of skin conductance using Wristband electrodes - Empatica E4
|
Month 3
|
|
Liver steatosis
기간: Month 3
|
measure of liver steatosis by MRI
|
Month 3
|
|
Liver steatosis
기간: Day 0
|
measure of liver steatosis by MRI
|
Day 0
|
|
Liver steatosis
기간: Day 0
|
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
|
Day 0
|
|
Liver steatosis
기간: Month 3
|
measure of liver steatosis by fibroscanner (ultrasonic attenuation)
|
Month 3
|
|
Liver steatosis
기간: month 3
|
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
|
month 3
|
|
Liver steatosis
기간: Day 0
|
measure of liver steatosis by Aixplorer (Lipersonic Imagine®)
|
Day 0
|
|
Liver fibrosis
기간: Day 0
|
measure of liver fibrosis by fibroscanner (liver stiffness)
|
Day 0
|
|
Liver fibrosis
기간: Month 3
|
measure of liver fibrosis by fibroscanner (liver stiffness)
|
Month 3
|
|
Liver fibrosis
기간: Month 3
|
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
|
Month 3
|
|
Liver fibrosis
기간: Day 0
|
measure of liver fibrosis by fibrotest (Lipersonic Imagine®)
|
Day 0
|
|
blood pressure
기간: Day0
|
measure of blood pressure using sphygmomanometer
|
Day0
|
|
blood pressure
기간: month 3
|
measure of blood pressure using sphygmomanometer
|
month 3
|
|
Fitness
기간: 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
기간: 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
기간: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
|
fat mass
기간: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
|
bone structure
기간: Month 3
|
measure of muscle mass using impedancemeter
|
Month 3
|
|
muscle mass
기간: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
|
fat mass
기간: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
|
bone structure
기간: Day 0
|
measure of muscle mass using impedancemeter
|
Day 0
|
|
muscle mass
기간: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
|
fat mass
기간: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
|
bone structure
기간: Day 0
|
measure of muscle mass using Densitometry X-ray absorption
|
Day 0
|
|
muscle mass
기간: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
|
fat mass
기간: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
|
bone structure
기간: Month 3
|
measure of muscle mass using Densitometry X-ray absorption
|
Month 3
|
|
muscle mass
기간: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
|
fat mass
기간: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
|
bone structure
기간: Month 3
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Month 3
|
|
muscle mass
기간: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
|
fat mass
기간: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
|
bone structure
기간: Day 0
|
measure of muscle mass using Peripheral quantitative computed tomography (pQCT)
|
Day 0
|
|
muscle mass
기간: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
|
fat mass
기간: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
|
bone structure
기간: Day 0
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Day 0
|
|
muscle mass
기간: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
|
fat mass
기간: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
|
bone structure
기간: Month 3
|
measure of muscle mass using Quantitative ultrasounds (QUS)
|
Month 3
|
|
depression
기간: 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
기간: 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
기간: 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
기간: 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
기간: Day 0
|
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
|
Day 0
|
|
General health
기간: Month 3
|
general health is assessed by the short form 36 health survey (SF36) composed by 36 items
|
Month 3
|
|
Stress
기간: day 0
|
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
day 0
|
|
Stress
기간: Month 3
|
stress is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Month 3
|
|
Fatigue
기간: Day 0
|
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Day 0
|
|
Fatigue
기간: Month 3
|
Fatigue is assessed by a Visuel analog scale of 100mm ranging from very low (0) to very high (100)
|
Month 3
|
|
Sleep
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Day 0
|
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
|
Day 0
|
|
Coping
기간: Month 3
|
Coping is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by an 11-point scale
|
Month 3
|
|
Emotions
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Month 3
|
Self-efficacy is assessed by the perceived self-efficacy scale composed by 10 items on a 4-point scale
|
Month 3
|
|
Alexithymia
기간: 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
기간: 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
기간: 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
기간: Month 3
|
Perception of illness is assessed by the Brief Illness Perception Questionnaire (B-IPQ) composed by a 11-point scale.
|
Month 3
|
|
Metacognition
기간: Day 0
|
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
|
Day 0
|
|
Metacognition
기간: Month 3
|
Metacognition is assessed by the MetaCognition Questionnaire (MCQ-30) composed by 30 items on a 5-point scale
|
Month 3
|
|
Time perception
기간: 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
기간: 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
기간: Day 0
|
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
|
Day 0
|
|
Physical activity
기간: Month 3
|
Physical activity is assessed by the Recent Physical Activity Questionnaire (RPAQ)
|
Month 3
|
|
Life style
기간: Day 0
|
life style is assessed with a questionnaire on coffee consumption, food intake, etc
|
Day 0
|
|
Life style
기간: Month 3
|
life style is assessed with a questionnaire on coffee consumption, food intake, etc
|
Month 3
|
|
cholesterol
기간: Day 0
|
measure by blood analyses to evaluate alloplastic load
|
Day 0
|
|
triglycerides
기간: Day 0
|
measure by blood analyses to evaluate alloplastic load
|
Day 0
|
|
cholesterol
기간: Month 3
|
measure by blood analyses to evaluate alloplastic load
|
Month 3
|
|
triglycerides
기간: Month 3
|
measure by blood analyses to evaluate alloplastic load
|
Month 3
|
|
Cortisol
기간: Day 0
|
hormone measure by blood analyses to evaluate alloplastic load
|
Day 0
|
|
Cortisol
기간: Month 3
|
hormone measure by blood analyses to evaluate alloplastic load
|
Month 3
|
|
DHEAS
기간: day 0
|
hormone measure by blood analyses to evaluate alloplastic load
|
day 0
|
|
DHEAS
기간: Month 3
|
hormone measure by blood analyses to evaluate alloplastic load
|
Month 3
|
|
BDNF
기간: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
|
BDNF
기간: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
|
CRP
기간: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
|
pro-inflammatory cytokines
기간: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
|
TNF alpha
기간: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
|
CRP
기간: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
|
pro-inflammatory cytokines
기간: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
|
TNF alpha
기간: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
|
NPY
기간: Month 3
|
proteins measure by blood analyses to evaluate alloplastic load
|
Month 3
|
|
NPY
기간: Day 0
|
proteins measure by blood analyses to evaluate alloplastic load
|
Day 0
|
|
Leptin
기간: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
|
Leptin
기간: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
|
Ghrelin
기간: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
|
Ghrelin
기간: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
|
NPY
기간: day 0
|
measure by blood analyses to evaluate appetite regulation
|
day 0
|
|
NPY
기간: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
|
adiponectine
기간: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
|
adiponectine
기간: Month 3
|
measure by blood analyses to evaluate appetite regulation
|
Month 3
|
|
CCK
기간: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
|
Month 3
기간: Day 0
|
measure by blood analyses to evaluate appetite regulation
|
Day 0
|
|
Insulin
기간: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
|
Insulin
기간: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
|
HbA1c
기간: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
|
HbA1c
기간: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
|
glucose
기간: Day 0
|
measure by blood analyses to evaluate glucid metabolism
|
Day 0
|
|
glucose
기간: Month 3
|
measure by blood analyses to evaluate glucid metabolism
|
Month 3
|
|
Albumin
기간: Day 0
|
measure by blood analyses to evaluate protid metabolism
|
Day 0
|
|
Albumin
기간: Month 3
|
measure by blood analyses to evaluate protid metabolism
|
Month 3
|
|
transthyretin
기간: Day 0
|
measure by blood analyses to evaluate protid metabolism
|
Day 0
|
|
transthyretin
기간: Month 3
|
measure by blood analyses to evaluate protid metabolism
|
Month 3
|
|
Homeostasis
기간: Day 0
|
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
|
Day 0
|
|
Homeostasis
기간: Month 3
|
measure of Fibroblast growth factor 23 (FGF23) by blood analyses to evaluate bone metabolism
|
Month 3
|
|
Osteoresorption
기간: Day 0
|
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
|
Day 0
|
|
Osteoresorption
기간: Month 3
|
measure of C-terminal Telopeptide of Type I collagen (CTx) by blood analyses to evaluate bone metabolism
|
Month 3
|
|
Osteoformation
기간: Day 0
|
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
|
Day 0
|
|
Osteoformation
기간: Month 3
|
measure of decarboxylated osteocalcine and BSAP by blood analyses to evaluate bone metabolism
|
Month 3
|
|
VEGF
기간: Day 0
|
measure by blood analyses to evaluate cardiovascular function
|
Day 0
|
|
VEGF
기간: Month 3
|
measure by blood analyses to evaluate cardiovascular function
|
Month 3
|
|
PAI1
기간: Day 0
|
measure by blood analyses to evaluate cardiovascular function
|
Day 0
|
|
PAI1
기간: Month 3
|
measure by blood analyses to evaluate cardiovascular function
|
Month 3
|
|
weight
기간: Day 0
|
measure of weight in kilograms
|
Day 0
|
|
weight
기간: Month 3
|
measure of weight in kilograms
|
Month 3
|
|
waist circumference
기간: Day 0
|
measure of waist circumference in centimetres
|
Day 0
|
|
waist circumference
기간: Month 3
|
measure of waist circumference in centimetres
|
Month 3
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2020년 9월 1일
기본 완료 (예상)
2021년 6월 1일
연구 완료 (예상)
2021년 6월 1일
연구 등록 날짜
최초 제출
2020년 2월 10일
QC 기준을 충족하는 최초 제출
2020년 3월 13일
처음 게시됨 (실제)
2020년 3월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 3월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 3월 13일
마지막으로 확인됨
2020년 2월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RBHP 2019 DUTHEIL
- 2019-A01804-53 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .