Clinical trial NCT05908877: Cardio-Metabolic Risk Evaluation in Overweight and Obese Children
Official title: Complex Assessment and Monitoring of Cardio-metabolic Risk in Overweight and Obese Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Obesity
Metabolic Syndrome
Nonalcoholic Fatty Liver
Atherosclerosis
Psychology
Cardiometabolic Syndrome
Keywords: Pediatric MetS, NAFLD, CIMT, Nutrition, Psychology
Lead sponsor: Neoped - Centru de Pediatrie
Sponsor class: OTHER
Collaborators: name: University of Medicine and Pharmacy "Victor Babes" Timisoara
name: West University of Timisoara
First posted: 2023-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The group or cohort of patients will be selected form the population that addresses the primary care clinic - pediatric center - Neoped.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from Baseline Body Mass Index in Overweight or Obese Children after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
measure: Changes from Baseline Systolic Blood Pressure in Overweight or Obese Children after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
measure: Changes from Baseline Diastolic Blood Pressure in Overweight or Obese Children after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
measure: Evaluation of Changes in Health-Related Quality of Life in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions, using the Pediatric Quality of Life Inventory (PedsQL)
timeFrame: 0,6 and 12 months
measure: Evaluation of Changes in Individual Self-Esteem in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions, using the Rosenberg self-esteem scale
timeFrame: 0,6 and 12 months
Secondary outcomes:
measure: Ultrasound Evaluation of Changes in Liver Echogenicity in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
measure: Ultrasound Evaluation of Changes in Visceral-to-Subcutaneous-Fat Ratio in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
measure: Changes of Carotid Intima-Media Thickness (CIMT) in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
measure: Changes from Baseline Serum Glucose Levels in Overweight or Obese Children after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
measure: Changes from Baseline Serum Lipid Levels in Overweight or Obese Children after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
measure: Changes from Baseline Liver Function Tests in Overweight or Obese Children after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
measure: Changes from Baseline Serum Insulin Levels in Overweight or Obese Children after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
measure: Changes from Baseline Inflammatory and Oxidative Stress Markers in Overweight or Obese Children after Physical Activity and Diet Interventions
timeFrame: 0,3,6 and 12 months
Other outcomes:
Locations:
city: Timişoara
country: Romania
facility: Neoped - Centru de Pediatrie
state: Timiş
Study officials:
affiliation: Neoped - Centru de Pediatrie; "Victor Babeș" University of Medicine and Pharmacy Timișoara, Romania
name: Teofana O Bizerea-Moga, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: