Cardio-Metabolic Risk Evaluation in Overweight and Obese Children

NCT05908877 | Unknown

• 1 other identifier: 01:Cardio_MetS_Ob
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pediatric MetS, NAFLD, CIMT, Nutrition, Psychology

Outcome Measures

Primary Outcomes (5)

• Changes from Baseline Body Mass Index in Overweight or Obese Children after Physical Activity and Diet Interventions

  Initial measurement of the body mass index (BMI) followed by three additional measurements at 3,6 and 12 months will be performed. These aim to assess the changes from baseline body mass index (BMI) in overweight or obese children, after physical activity and diet interventions. Overweight and obesity are defined using age-specific BMI reference guidelines from the 2000 Centers for Disease Control and Prevention Child Growth Charts. Thus, overweight assumes BMI values between the 85th and 95th percentiles, and obesity implies values above the 95th percentile.

  0,3,6 and 12 months

• Changes from Baseline Systolic Blood Pressure in Overweight or Obese Children after Physical Activity and Diet Interventions

  Initial evaluation of systolic blood pressure followed by three reevaluations at 3,6 and 12 months will be performed. These aim to assess the changes from baseline systolic blood pressure in overweight or obese children, after physical activity and diet interventions. Arterial hypertension is diagnosed as a blood pressure value (systolic, diastolic or both), measured in mmHg, over the 95th percentile for age.

  0,3,6 and 12 months

• Changes from Baseline Diastolic Blood Pressure in Overweight or Obese Children after Physical Activity and Diet Interventions

  Initial evaluation of diastolic blood pressure followed by three reevaluations at 3,6 and 12 months will be performed. These aim to assess the changes from baseline diastolic blood pressure in overweight or obese children after physical activity and diet interventions. Arterial hypertension is diagnosed as a blood pressure value (systolic, diastolic or both), measured in mmHg, over the 95th percentile for age.

  0,3,6 and 12 months

• 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)

  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. PedsQL will be used at the child's first assessment and reapplied at each control visit. Items on the PedsQL Generic Core Scales are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life: 0 ("Never") = 100 1. ("Almost Never") = 75 2. ("Sometimes") = 50 3. ("Often") = 25 4. ("Almost Always") = 0 Scale scores are computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of items or more are missing, the Scale Score should not be computed.

  0,6 and 12 months

• 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

  This scale is composed of 10 questions and measures positive and negative feelings about the self. The answer range is from strongly agree to strongly disagree. The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.

  0,6 and 12 months

Secondary Outcomes (8)

• Ultrasound Evaluation of Changes in Liver Echogenicity in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions

  0,3,6 and 12 months

• Ultrasound Evaluation of Changes in Visceral-to-Subcutaneous-Fat Ratio in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions

  0,3,6 and 12 months

• Changes of Carotid Intima-Media Thickness (CIMT) in Children diagnosed with Overweight or Obesity after Physical Activity and Diet Interventions

  0,3,6 and 12 months

• Changes from Baseline Serum Glucose Levels in Overweight or Obese Children after Physical Activity and Diet Interventions

  0,3,6 and 12 months

• Changes from Baseline Serum Lipid Levels in Overweight or Obese Children after Physical Activity and Diet Interventions

  0,3,6 and 12 months

Study Arms (1)

Overweight and Obese Children

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.

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

Interventions

History and Clinical evaluation OTHER

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

Overweight and Obese Children

Biological evaluation of the metabolic syndrome and components DIAGNOSTIC_TEST

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)

Overweight and Obese Children

Ultrasound evaluation of subclinical atherosclerosis and visceral fat storage DIAGNOSTIC_TEST

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

Overweight and Obese Children

Nutritional assessment OTHER

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.

Overweight and Obese Children

Psychological evaluation of the impact of obesity/overweight BEHAVIORAL

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.

Overweight and Obese Children

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neoped - Centru de Pediatrie: lead
• University of Medicine and Pharmacy "Victor Babes" Timisoara: collaborator
• West University of Timisoara: collaborator

Study Sites (1)

Neoped - Centru de Pediatrie

Timișoara, Timiș County, 300425, Romania

Location

MeSH Terms

Conditions

Pediatric Obesity; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Atherosclerosis

Interventions

Health Records, Personal; Nutrition Assessment

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Teofana O Bizerea-Moga, MD PhD

  Neoped - Centru de Pediatrie; "Victor Babeș" University of Medicine and Pharmacy Timișoara, Romania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teofana O Bizerea-Moga, MD PhD

CONTACT

+40729093725; bizerea.teofana@umft.ro

Cornel Musei

CONTACT

neoped.medica@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: June 18, 2023
• Study Start: July 10, 2023
• Primary Completion: December 10, 2023
• Study Completion: July 10, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

RO (1)