Lifestyle Interventions and Metabolic Profile in Obese Children

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728621
• Other study ID #: 139/2010/CE
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: June 2018

Study information

• Verified date: October 2018
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Childhood Obesity
• Dyslipidemias
• Life Style
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Normocaloric and balanced diet, physical activity
Promotion of normocaloric & balanced diet and physical activity

Locations

Country	Name	City	State
Italy	Ospedale San Paolo	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height	Expressed in meters	0 (t0)-12 months (t1)
Primary	Blood levels of total cholesterol		0 (t0)-12 months (t1)
Primary	Weight	Expressed in Kilograms	0 (t0)-12 months (t1)
Primary	Body Mass Index (BMI)	Expressed in kg/m^2	0 (t0)-12 months (t1)
Primary	Waist-to-height ratio	The ratio between waist circumference (cm) and height (cm)	0 (t0)-12 months (t1)
Primary	Waist circumference	Expressed in cm	0 (t0)-12 months (t1)
Primary	Triceps Skinfold Thickness	Expressed in mm, measured with an accurate plicometer	0 (t0)-12 months (t1)
Primary	Tanner Stage	Classification of sexual maturation according to Tanner criteria	0 (t0)-12 months (t1)
Primary	Blood levels of LDL cholesterol		0 (t0)-12 months (t1)
Primary	Blood levels of HDL cholesterol		0 (t0)-12 months (t1)
Primary	Blood levels of triglycerides		0 (t0)-12 months (t1)
Primary	Blood levels of apolipoprotein A1 (ApoA1)		0 (t0)-12 months (t1)
Primary	Blood levels of apolipoprotein B (ApoB)		0 (t0)-12 months (t1)
Primary	Blood levels of insulin		0 (t0)-12 months (t1)
Primary	Blood levels of glucose		0 (t0)-12 months (t1)
Primary	HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR)	calculated as the product of fasting glucose (mmol/L) and fasting insulin (U/mL) divided by 22.5	0 (t0)-12 months (t1)
Primary	QUantitative Insulin sensitivity ChecK (QUICK) index	1/[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)]	0 (t0)-12 months (t1)
Primary	HOMA-ß%	[20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5]	0 (t0)-12 months (t1)
Primary	Triglyceride-Glucose index (TyG index)	ln[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2]	0 (t0)-12 months (t1)
Primary	Atherogenic Index of Plasma (AIP)	log10 of the ratio of plasma triglycerides to HDL-cholesterol	0 (t0)-12 months (t1)