跳至主要内容
临床试验/NCT04310371
NCT04310371Unknown不适用

Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
cardiac ectopic fat deposits

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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
  • Alcohol consumption
  • Intense physical activity in competition

结局指标

主要结局

cardiac ectopic fat deposits

时间窗: Day 0

Quantification of cardiac ectopic fat deposits (thickness using echocardiography)

left myocardial regional function

时间窗: Day 0

left myocardial regional function (echocardiography)

次要结局

  • transthyretin(Month 3)
  • glucose(Month 3)
  • VEGF(Month 3)
  • heart rate variability(Day 0)
  • skin conductance(Month 3)
  • macrovascularisation(Month 3)
  • blood pressure(month 3)
  • Fitness(Day 0)
  • pro-inflammatory cytokines(Month 3)
  • depression(Month 3)
  • anxiety(Month 3)
  • General health(Month 3)
  • Stress(Month 3)
  • Fatigue(Month 3)
  • Sleep(Month 3)
  • Burnout(Month 3)
  • Mindfulness(Month 3)
  • Coping(Month 3)
  • Emotions(Month 3)
  • Perception of work(Month 3)
  • Self-efficacy(Month 3)
  • Illness perception(Month 3)
  • Alexithymia(Month 3)
  • Metacognition(Month 3)
  • Time perception(Month 3)
  • Physical activity(Month 3)
  • Life style(Month 3)
  • cholesterol(Month 3)
  • triglycerides(Month 3)
  • DHEAS(Month 3)
  • Cortisol(Month 3)
  • BDNF(Month 3)
  • TNF alpha(Month 3)
  • Leptin(Month 3)
  • CRP(Month 3)
  • Ghrelin(Month 3)
  • adiponectine(Month 3)
  • PAI1(Month 3)
  • weight(Month 3)
  • Homeostasis(Month 3)
  • Osteoresorption(Month 3)
  • waist circumference(Month 3)
  • CCK(Day 0)
  • Month 3(Day 0)
  • Insulin(Month 3)
  • Albumin(Month 3)
  • HbA1c(Month 3)
  • Osteoformation(Month 3)
  • Liver steatosis(Day 0)
  • Liver fibrosis(Day 0)
  • muscle mass(Month 3)
  • fat mass(Month 3)
  • bone structure(Month 3)
  • NPY(Month 3)
  • microvascularisation(Month 3)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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