Cardio-Metabolic Risk Evaluation in Overweight and Obese Children (CardMetSOb)

Neoped - Centru de Pediatrie

Status: Not yet enrolling

Conditions: Nonalcoholic Fatty Liver; Cardiometabolic Syndrome; Psychology; Pediatric Obesity; Atherosclerosis; Metabolic Syndrome

Treatments: Other: History and Clinical evaluation; Other: Nutritional assessment; Behavioral: Psychological evaluation of the impact of obesity/overweight; Diagnostic Test: Biological evaluation of the metabolic syndrome and components; Diagnostic Test: Ultrasound evaluation of subclinical atherosclerosis and visceral fat storage

Study type: Observational

Funder types: Other

Identifiers

NCT05908877

01:Cardio_MetS_Ob

Details and patient eligibility

About

Metabolic and cardio-vascular complications can often appear in overweight and obese children from an early age. Currently, there are few studies in the specialized literature that correlate clinical, biological and ultrasound parameters in order to stratify cardio-metabolic risk in obese children. Also, the specialized literature is poor regarding longitudinal follow-up and the importance of diet for reducing metabolic and cardiovascular complications in these children.

This study is designed to assess the hypothesis that the sustained improvement of lifestyle with regard to nutrition and exercise can reverse cardiometabolic multimorbidities in obese children as assessed by clinical, biological and ultrasound evaluation.

Full description

The Metabolic Syndrome (MetS) is a group of metabolic conditions that increase the risk of cardiovascular events, insulin resistance and type 2 diabetes. Obesity is often the first stage in the subsequent development of MetS. Further, one or more changes may occur, such as: an increase in triglycerides, low-density lipoprotein cholesterol (LDL-C), insulin resistance and blood pressure, respectively a decrease in high-density lipoprotein cholesterol (HDL-C) and glucose tolerance.

The term "nonalcoholic fatty liver disease" (NAFLD) refers to a spectrum of conditions ranging from steatosis to nonalcoholic steatohepatitis (NASH) and fibrosis rather than a single entity. The main risk factors are obesity and the metabolic dysregulations that it causes. Obesity contributes to the development of NAFLD because it not only leads to metabolic imbalance but also increases oxidative stress and mitochondrial dysfunction.

An early indication of metabolic and cardiovascular subclinical disease, is represented by an increase of the carotid intima-media thickness (CIMT), of subcutaneous and visceral adipose tissue, as well as the fatty liver deposition. B-mode ultrasound allows measuring of all these parameters thereby contributing to the early detection of changes at these levels.

The ever-increasing incidence of pediatric obesity, enhanced by the recent coronavirus (COVID-19) pandemic, imposes the need for clinical, paraclinical-imaging, biological, nutritional and psychological evaluation and monitoring of this population.

The study aims to develop an algorithm for the complex assessment of cardio-metabolic risk in overweight and obese children on the one hand, as well as to reduce this risk by establishing a nutrition and physical activity plan simultaneously with a continuous monitoring of the results obtained following this plan, on the other side.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• clinical diagnosis of overweight or obesity
• informed consent of caregivers

Exclusion criteria

• lean/normal weight subjects
• monogenic or syndromic obesity
• endocrine obesity (e.g., hypothyroidism, Cushing's syndrome)
• medication-induced obesity
• associated chronic diseases (other than components of the metabolic syndrome)
• lack of informed consent of caregivers

Trial design

50 participants in 1 patient group

Overweight and Obese Children

Description:

Children diagnosed as overweight or obese, defined by the Centers for Disease Control and Prevention (CDC) as a BMI between the 85th and 95th percentile, or above the 95th percentile for the same age and sex, respectively.

Treatment:

Other: Nutritional assessment

Diagnostic Test: Biological evaluation of the metabolic syndrome and components

Other: History and Clinical evaluation

Diagnostic Test: Ultrasound evaluation of subclinical atherosclerosis and visceral fat storage

Behavioral: Psychological evaluation of the impact of obesity/overweight