Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312280
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-12
Brief Title:
Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity
Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Organization:
Azienda Ospedaliero Universitaria Maggiore della Carita
Study Overview
Official Title:
Obiasity Study Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBIASITY
Brief Summary:
In recent decades the prevalence of obesity and overweight has dramatically increased globally representing a serious problem for society and for the health system of many countries estimating an impact of 2-8 on global health spending Obesity and overweight represent a problem not only for adults but also for children and adolescents the latest data from the WHO estimate that about 340 million children and adolescents between 5 and 19 years are overweight or obese data that increase drastically since 1975 from 4 of boys to 18 in 2016 World Health Organization WHO The reduction and prevention of overweight and obesity in childhood is one of the main missions of public health at the global level both for short-term and long-term implications Recently the importance of bioprothesiometric analysis BIA in the clinical routine has been evaluated as it allows an estimation of body composition that would not otherwise be provided by the growth curves and the calculation of the Body Mass Index BMI In this study the investigators want to evaluate in addition to the classic clinical parameters the body composition of patients evaluated by means of an impedance balance named TANITA MC780 MA P With this study the investigators aim to investigate possible clinical and body composition changes in children and adolescents suffering from overweight and obesity with the ultimate aim of reducing cardio-metabolic risk factors related to it
The objective of the study is the assessment of body composition as an indicator of accuracy of lean mass but especially of fat mass of pediatric patients who are overweight and obesity in order to carry out a more complete evaluation of the clinical-metabolic condition for the prevention of cardiovascular risk
The secondary objective is to assess the dietary compliance of the patients being studied and the possible correlation with the body composition
The objective of the study is the assessment of body composition as an indicator of accuracy of lean mass but especially of fat mass of pediatric patients who are overweight and obesity in order to carry out a more complete evaluation of the clinical-metabolic condition for the prevention of cardiovascular risk
The secondary objective is to assess the dietary compliance of the patients being studied and the possible correlation with the body composition
Detailed Description:
MATERIALS AND METHODS
The study will include all children and adolescents who visit the SCDU Struttura Complessa a Direzione Universitaria of Pediatrics Surgery of Endocrinology and Auxology of the Major Charity Hospital of Novara for first visit or checkup for excess weight between 1 January 2024 and 30 May 2024 of both sexes that meet the following criteria of inclusion
Criteria for inclusion
Age between 6 and 17 years BMI compatible with obesity or overweight according to International Obesity Task Force IOTF criteria Signature of informed consent by parentslegal guardians
Criteria for exclusion
Age below 6 years or over 18 Previous diagnosis of diabetes mellitus type 2 already placed in dietary or pharmacological therapy Subjects already included in dieto-therapeutic regimen Obesity secondary to diseases genetic Prader Willi syndrome Down syndrome metabolic and endocrine Cushing syndrome hypothyroidism
Informed consent After reading the study fact sheet patients will only be enrolled after the signature of the informed consent form by both parents or the legal representative and the minor subjects recruited see patient and parentguardian information attached to the protocol
Upon enlistment V1 the subjects included will undergo a clinical examination in accordance with normal practice in which a bioimpedance analysis for the assessment of body composition is provided The impedance analysis will be carried out using TANITA MC-780MA balance
After the bioimpedance analysis and the clinical visit a food scheme based on the Mediterranean Diet will be delivered The composition of the diet will be distributed as follows 55-60 of carbohydrates 45-50 complex carbohydrates and no more than 10 of simple sugars 25-30 of lipids and 15 of proteins It will be studied in accordance with the Reference Nutrient and Energy Intake Levels LARN Italian Society of Human Nutrition 2014 guidelines
Follow-up Patients will be evaluated at the time of enrollment V1 after 3 months V3 and after 6 months V6 as per clinical practice
At the recruitment visit V1 the following demographic and medical history of the patient and family will be collected
sex gender age years ethnicity weight and length at birth type and duration of breastfeeding age of parents years family history of previous diseases Arterial Hypertension Dyslipidemia Hepatic Steatosis Diabetes specify if type I or II and oral or insulin therapy and cardiovascular pathology the smoking habit of parents presence of gestational maternal diabetes socioeconomic level of the family nucleus
At all times V1V3V6 the following assessments will be made
Anthropometric measurements Height Weight BMI and BMI standard deviation score SDS Growth percentile according to Cacciari curves Waisthips circumference waistheight ratio Bioimpedance Pa and heart rate Stadium of Tanner Eating habits and medical history Semi-quantitative food frequency questionnaire 24h recall Questionnaire of adherence to the Mediterranean diet called Quality Index for Children and Adolescents KIDMED Questionnaire on daily physical activity IPAQ
Biochemical assessments will also be carried out at the beginning and end of the protocol V1 and V6 according to normal clinical practice basic blood chemistry andor OGTT The analysis will be carried out at the clinical biochemistry laboratory of the University hospital AOU- Azienda Ospedaliero Universitaria Major of Charity of Novara
During the biochemical evaluations two serum and two plasma samples will be taken for Asprosin Irisin and Ghrelin for the research of new markers related to obesity and its complications The analysis will be carried out at the Laboratory of Biochemistry of the University of Eastern Piedmont The determination of clinical parameters will be carried out locally at the clinic of Auxologia and Pediatric Endocrinology of the Pediatric Clinic of the Major Hospital of Charity of Novara while the examination of the BIA will be carried out at the Endocrinology Clinic of the Major Hospital of Charity of Novara
EXPECTED RESULTS It is expected a change in the body mass index based on the BMI z-score and an improvement in body composition after 6 months from the first visit and then from the implementation of the dietary scheme In addition an improvement in metabolic parameters is expected insulin resistance glycidic intolerance dyslipidemia hepatic steatosis
The study will include all children and adolescents who visit the SCDU Struttura Complessa a Direzione Universitaria of Pediatrics Surgery of Endocrinology and Auxology of the Major Charity Hospital of Novara for first visit or checkup for excess weight between 1 January 2024 and 30 May 2024 of both sexes that meet the following criteria of inclusion
Criteria for inclusion
Age between 6 and 17 years BMI compatible with obesity or overweight according to International Obesity Task Force IOTF criteria Signature of informed consent by parentslegal guardians
Criteria for exclusion
Age below 6 years or over 18 Previous diagnosis of diabetes mellitus type 2 already placed in dietary or pharmacological therapy Subjects already included in dieto-therapeutic regimen Obesity secondary to diseases genetic Prader Willi syndrome Down syndrome metabolic and endocrine Cushing syndrome hypothyroidism
Informed consent After reading the study fact sheet patients will only be enrolled after the signature of the informed consent form by both parents or the legal representative and the minor subjects recruited see patient and parentguardian information attached to the protocol
Upon enlistment V1 the subjects included will undergo a clinical examination in accordance with normal practice in which a bioimpedance analysis for the assessment of body composition is provided The impedance analysis will be carried out using TANITA MC-780MA balance
After the bioimpedance analysis and the clinical visit a food scheme based on the Mediterranean Diet will be delivered The composition of the diet will be distributed as follows 55-60 of carbohydrates 45-50 complex carbohydrates and no more than 10 of simple sugars 25-30 of lipids and 15 of proteins It will be studied in accordance with the Reference Nutrient and Energy Intake Levels LARN Italian Society of Human Nutrition 2014 guidelines
Follow-up Patients will be evaluated at the time of enrollment V1 after 3 months V3 and after 6 months V6 as per clinical practice
At the recruitment visit V1 the following demographic and medical history of the patient and family will be collected
sex gender age years ethnicity weight and length at birth type and duration of breastfeeding age of parents years family history of previous diseases Arterial Hypertension Dyslipidemia Hepatic Steatosis Diabetes specify if type I or II and oral or insulin therapy and cardiovascular pathology the smoking habit of parents presence of gestational maternal diabetes socioeconomic level of the family nucleus
At all times V1V3V6 the following assessments will be made
Anthropometric measurements Height Weight BMI and BMI standard deviation score SDS Growth percentile according to Cacciari curves Waisthips circumference waistheight ratio Bioimpedance Pa and heart rate Stadium of Tanner Eating habits and medical history Semi-quantitative food frequency questionnaire 24h recall Questionnaire of adherence to the Mediterranean diet called Quality Index for Children and Adolescents KIDMED Questionnaire on daily physical activity IPAQ
Biochemical assessments will also be carried out at the beginning and end of the protocol V1 and V6 according to normal clinical practice basic blood chemistry andor OGTT The analysis will be carried out at the clinical biochemistry laboratory of the University hospital AOU- Azienda Ospedaliero Universitaria Major of Charity of Novara
During the biochemical evaluations two serum and two plasma samples will be taken for Asprosin Irisin and Ghrelin for the research of new markers related to obesity and its complications The analysis will be carried out at the Laboratory of Biochemistry of the University of Eastern Piedmont The determination of clinical parameters will be carried out locally at the clinic of Auxologia and Pediatric Endocrinology of the Pediatric Clinic of the Major Hospital of Charity of Novara while the examination of the BIA will be carried out at the Endocrinology Clinic of the Major Hospital of Charity of Novara
EXPECTED RESULTS It is expected a change in the body mass index based on the BMI z-score and an improvement in body composition after 6 months from the first visit and then from the implementation of the dietary scheme In addition an improvement in metabolic parameters is expected insulin resistance glycidic intolerance dyslipidemia hepatic steatosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None