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临床试验/NCT03728621
NCT03728621已完成不适用

Individual Versus Group-based Lifestyle Intervention in Obese Children: Effects on Anthropometry and Metabolic Profile

University of Milan2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
2
主要终点
Waist circumference

研究概览

简要总结

This study evaluates if promotion of a normocaloric and balanced diet and of physical activity, through an individual- or group-based lifestyle intervention of 12 months, may affect anthropometric measurements and metabolic profile in obese children.

详细描述

Obese children are at risk of metabolic and cardiovascular complications both during pediatric age and later and they often show components of metabolic syndrome, such as dyslipidemia, hypertension and disturbed glucose metabolism . These complications are strictly associated with insulin resistance/hyperinsulinemia which is one of the most important contributing factors to cardiovascular disease. The gold standard technique to determine whole-body insulin sensitivity, the hyperinsulinemic-euglycemic clamp, is expensive, invasive and requires considerable expertise to be performed. Therefore, several surrogate measures have been developed. Among these, the triglyceride-glucose index (TyG) is a useful indicator, providing an easily and widely available simple laboratory method as a surrogate to estimate insulin resistance in adult, children and adolescents. Other useful indicators of insulin resistance and insulin sensitivity are the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check (QUICK) index, respectively, while HOMA-β% is useful to evaluate pancreatic β-cell function.

Among cardiovascular complications, obesity-related atherogenic dyslipidemia is a risk factor for cardiovascular disease. In childhood, atherogenic dyslipidemia may be associated with structural and functional vascular changes, as increased carotid intima-media thickness and increased arterial stiffness. The atherogenic index of plasma (AIP) is a recognized valuable indicator of the size of pre- and anti-atherogenic lipoprotein particle and is considered a major predictive marker of atherosclerosis risk. Additionally, it might be more promising than other lipid variables in assessing cardiovascular risk.

Guidelines for treatment of childhood obesity recommend intensive lifestyle interventions, involving diet, physical activity and behavior change, in an age-appropriate manner. While it is recognized that these interventions could favorably influence some variables of metabolic profile of obese children, no study has reported accurate possible effect on triglyceride-glucose index and atherogenic index of plasma. Furthermore, pediatric obesity interventions may be group and/or individual-based. The group-based intervention requires less resources, children may benefit from a positive social environment, but the attention to individual needs is limited, which may weaken outcomes. On the other hand, the individual-based intervention allows to tailor dietary and physical counselling on individual's needs but is more expensive and requires greater resources.

The aims of the study are to establish in patients who undergone individual versus group based intervention:

  1. Effect on adiposity measured by BMI-zScore
  2. effect on gluco-insulin metabolism evaluated by homa-index
  3. effect on lipid profile evaluated by aterogenic index (AIP)

研究设计

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

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Obesity confirmed by BMI z-score >2 according to WHO growth charts
  • Age at recruitment ≥6 years
  • weight at birth ≥2500 g and <4000 g
  • gestational age 37-42 weeks
  • single birth
  • Caucasian ethny
  • family residing in Milan or neighborhood (≤30 km)

排除标准

  • Syndromic, organic and hormonal conditions besides obesity
  • Age at recruitment <6 years
  • Low birthweight (<2500 g), birthweight >4000 g
  • Pre-term or post-term birth
  • Twin delivery
  • Other ethnies than Caucasian

结局指标

主要结局

Waist circumference

时间窗: 0 (t0)-12 months (t1)

Expressed in cm

Height

时间窗: 0 (t0)-12 months (t1)

Expressed in meters

Tanner Stage

时间窗: 0 (t0)-12 months (t1)

Classification of sexual maturation according to Tanner criteria

Blood levels of LDL cholesterol

时间窗: 0 (t0)-12 months (t1)

Blood levels of apolipoprotein A1 (ApoA1)

时间窗: 0 (t0)-12 months (t1)

Blood levels of glucose

时间窗: 0 (t0)-12 months (t1)

Triglyceride-Glucose index (TyG index)

时间窗: 0 (t0)-12 months (t1)

ln\[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2\]

Blood levels of total cholesterol

时间窗: 0 (t0)-12 months (t1)

Weight

时间窗: 0 (t0)-12 months (t1)

Expressed in Kilograms

Triceps Skinfold Thickness

时间窗: 0 (t0)-12 months (t1)

Expressed in mm, measured with an accurate plicometer

Body Mass Index (BMI)

时间窗: 0 (t0)-12 months (t1)

Expressed in kg/m\^2

Waist-to-height ratio

时间窗: 0 (t0)-12 months (t1)

The ratio between waist circumference (cm) and height (cm)

Blood levels of HDL cholesterol

时间窗: 0 (t0)-12 months (t1)

Blood levels of insulin

时间窗: 0 (t0)-12 months (t1)

HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR)

时间窗: 0 (t0)-12 months (t1)

calculated as the product of fasting glucose (mmol/L) and fasting insulin (U/mL) divided by 22.5

Atherogenic Index of Plasma (AIP)

时间窗: 0 (t0)-12 months (t1)

log10 of the ratio of plasma triglycerides to HDL-cholesterol

Blood levels of triglycerides

时间窗: 0 (t0)-12 months (t1)

Blood levels of apolipoprotein B (ApoB)

时间窗: 0 (t0)-12 months (t1)

QUantitative Insulin sensitivity ChecK (QUICK) index

时间窗: 0 (t0)-12 months (t1)

1/\[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)\]

HOMA-β%

时间窗: 0 (t0)-12 months (t1)

\[20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5\]

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elvira Verduci

MD PhD Assistant professor in Pediatrics

University of Milan

研究点 (2)

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