NCT05908877

Cardio-Metabolic Risk Evaluation in Overweight and Obese Children

Complex Assessment and Monitoring of Cardio-metabolic Risk in Overweight and Obese Children

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Neoped - Centru de Pediatrie · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pediatric Obesity
• Metabolic Syndrome
• Nonalcoholic Fatty Liver
• Atherosclerosis
• Psychology
• Cardiometabolic Syndrome

Interventions

Type	Name	Description
OTHER	History and Clinical evaluation	HISTORY and CLINICAL EVALUATION and recording of the following parameters: * Gestational Age * Birth Weight * Gender * Weaning habits * Anthropometric indices: actual age; actual weight; actual height; body mass index BMI (kg/m2) + percentile; waist circumference; age for height; weight for height; height for age; height standard deviation score (SDS) * Vital parameters: heart rate (beats/min); respiratory rate (breaths/min); blood pressure (mmHg) * Adipose tissue * Subcutaneous fat tissue distribution * Acanthosis Nigricans * Stretch marks (striae) * Tanner Puberty Stage
DIAGNOSTIC_TEST	Biological evaluation of the metabolic syndrome and components	LABORATORY INVESTIGATIONS will include: * Lipid Profile: total cholesterol (mmol/L); LDL - cholesterol (mmol/L); HDL - cholesterol (mmol/L); triglycerides (mmol/L) * Glucose - Insulin Profile: HbA1c (%); serum glucose (mmol/L); insulinemia (µUI/mL); HOMA Index * Liver Function: alanine aminotransferase (ALT or TGP) (U/L); gamma glutamyl transferase (GGT) (U/L) * Cardio-Vascular Risk - Inflammation - Oxidative Stress: ultrasensitive C-reactive protein (ng/mL); leptin (ng/mL); adiponectin (ng/mL); serum selenium (μg/L); glutathione peroxidase (GPx) (U/L)
DIAGNOSTIC_TEST	Ultrasound evaluation of subclinical atherosclerosis and visceral fat storage	ULTRASOUND EVALUATION by: * Carotid Intima-Media Thickness (cIMT) Measurement using B-Mode ultrasound (Samsung Medison UGEO H60 Ultrasound System, Samsung Medison CO., LTD., Seoul Korea) with a high frequency linear array probe (5-13 MHz) and a semi-automated software (Auto IMT+), according to the Mannheim Consensus * Measurements of Visceral-to-Subcutaneous-Fat Ratio using B-Mode ultrasound (Samsung Medison UGEO H60 Ultrasound System, Samsung Medison CO., LTD., Seoul Korea) with a 7.5 (12) MHz linear transducer for subcutaneous fat and a 3.5 MHz convex transducer for visceral fat measurement * Ultrasound Quantification of Hepatic Steatosis: assessed with B-Mode ultrasound (Samsung Medison UGEO H60 Ultrasound System, Samsung Medison CO., LTD., Seoul Korea) using 3.5 MHz convex transducer; increased liver echogenicity, blurring of vascular margins and increased acoustic attenuation are the parameters considered in the quantification of hepatic steatosis
OTHER	Nutritional assessment	NUTRITION CONSULT Initial consult will include: food habits survey aiming at identifying the nutritional factors that led to an increased Body Mass Index (BMI) and recommendations At reevaluations the food diary of the patients will be evaluated and recommendations will be adapted accordingly. The final visit will include evaluation of the food diary looking to identify the factors that have or have not helped to normalize BMI in order to recommend a long-term healthy lifestyle.
BEHAVIORAL	Psychological evaluation of the impact of obesity/overweight	PSYCHOLOGICAL ASSESSMENT by: Evaluation of pediatric health-related quality of life will be assessed with Pediatric Quality of Life Inventory (PedsQL). The questionnaire has 23 items and undertakes the four types of functioning: physical, emotional, social, and educational. It can be filled in by children as well as parents. Higher scores indicate better health-related quality of life. Another questionnaire that will be used is the the Rosenberg Self-Esteem Scale. It is composed of 10 questions and measures positive and negative feelings about the self. The answer range is from strongly agree to strongly disagree. A higher score means higher self-esteem. Drawing in children is a communicative tool, many times more than reading or language. It can measure the image of the self and the image of the others and is representative of the unconscious. Questionnaires and drawing interpretation will be done at the initial presentation and at every control visit.

Timeline

• Start date: 2023-07-10
• Primary completion: 2023-12-10
• Completion: 2024-07-10
• First posted: 2023-06-18
• Last updated: 2023-06-18

Locations

1 site across 1 country: Romania