ObesityNCT04694937
Metabolically Healthy Obesity in Pediatric Population
An observational study of Obesity and Pediatric Obesity, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The global epidemic of childhood obesity, with the accompanying rise in the prevalence of endocrine, metabolic, and cardiovascular comorbidities in youth, represents one of the most important public health issues of the modern world. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Obesity, Pediatric Obesity, Metabolic Syndrome
- What is being tested?
- heart rate variabilty measured by pulse oximetry
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 30 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Child, Adult
Study population: The study will be performed in the Nutrition and Obesity Clinic of the Pediatric Gastroenterology Unit at "Dana Dwek" Children's Hospital. All children and adolesecnt that that will be admitted to our clinic between December 2020 to December 2022 will include in the study.
Who may be able to join
- All children 10-18 with obesity, males and females, who attend the obesity clinic in the pediatric gastroenterology unit at "Dana-Dwek" children's hospital, Tel Aviv Sourasky Medical Center, will be included
Who cannot join
- Children with conditions that may affect HRV (e.g. congenital or acquired heart disease, other inflammatory conditions) will be excluded.
- withdrawal criteria: children and parents that will refuse to participate in the telephone interview will withdrawl from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Metabolically Healthy Obesity in Pediatric Population- Prevalence, Predictors and the Effect of Heart Rate Variability
The global epidemic of childhood obesity, with the accompanying rise in the prevalence of endocrine, metabolic, and cardiovascular comorbidities in youth, represents one of the most important public health issues of the modern world. Nevertheless, a distinct subgroup of youth with obesity less prone to the development of metabolic disturbances, called "metabolically healthy obese" (MHO), has come into focus. Defining the MHO subpopulation within the youth with obesity is of high importance in order to elucidate the mechanisms protecting against the clustering of cardiometabolic risk factors, and for its clinical, preventive, and therapeutic decision-making implications. Little is known about the mechanisms of development of metabolic disturbance in pediatric obesity. Cardiac autonomic function, which can be measured non-invasively with heart rate variability (HRV), has been suggested as a potential mechanism underlying the development of metabolic syndrome and cardiovascular disease. The aims of the present study were to investigate clinical, anthropometric, and socio-demographic and lifestyle predictors of MHO in this group and to asses correlation between HRV and the metabolic syndrome progression or improvement , in order to reveal if HRV can serve as a predictor to metabolic disturbance in pediatric obesity population Materials and Methods The study will be performed in the Nutrition and Obesity Clinic of the Pediatric Gastroenterology Unit at "Dana Dwek" Children's Hospital. All children and adolescents that that will be admitted to our clinic between January 2021 to December 2022 will include in the study. sociodemographic parameters will be collected from the medical files.Blood will be drawn for complete metabolic assesment. MUO children will be defined according to the recent international definition. Resting HRV will be measured by Pulse Oximeter (BM2000A/Shanghai Berry Electronic Tech Co., Ltd.). The measurement will be performed twice - at two consecutive visits at the clinic, as part as the routine follow up of the patient every 3 months.
Read the detailed description
Scientific background:
The global epidemic of childhood obesity, with the accompanying rise in the prevalence of endocrine, metabolic, and cardiovascular comorbidities in youth, represents one of the most important public health issues of the modern world (1-4). The earlier occurrence and increase in the prevalence of both pediatric obesity and metabolic syndrome (MS) leads to a potential decline in life expectancy, meaning that the youth of today could be the first generation to live shorter lives than their parents (2, 4-6).
In the context of the childhood obesity pandemic, a distinct subgroup of youth with obesity less prone to the development of metabolic disturbances, called "metabolically healthy obese" (MHO), has come into focus (7, 8). Despite having obesity, MHO individuals display a "favorable" metabolic profile, with preserved insulin sensitivity, normal blood pressure and glucose regulation, normal lipids and liver enzymes, as well as a normal hormonal, inflammation, and immune profile (9-13). Although MHO status might not necessarily translate into lower mortality, and can crossover to "metabolically unhealthy obese" (MUO) phenotype during puberty, defining the MHO subpopulation within the youth with obesity is of high importance in order to elucidate the mechanisms protecting against the clustering of cardiometabolic risk factors, and for its clinical, preventive, and therapeutic decision-making implications (4, 7, 13-15).
Few studies evaluated predictors and risk factors for MUO (14-15). However, these were based on variety of definitions and criteria used for defining MHO. moreover, little is known about the mechanisms of development of metabolic disturbance in pediatric obesity. More data is needed in order to identify the parameters which have the highest ability to predict clinically significant outcomes. Cardiac autonomic function, which can be measured non-invasively with heart rate variability, has been suggested as a potential mechanism underlying the development of metabolic syndrome and cardiovascular disease (16). Autonomic dysfunction characterized by reduced heart rate variability was found to predict coronary heart disease, type 2 diabetes mellitus and of all-cause and cardiac mortality (17-20) in adult population. However, the effect of reduced heart rate variability on metabolic syndrome in pediatric population and the influence of nutritional intervention with weight reduction on heart rate variability is not known. We aimed to investigate clinical, anthropometric, and socio-demographic and lifestyle predictors of MHO in this group, to describe HRV in children with obesity, and to find correlation to the metabolic syndrome or metabolic syndrome progression or improvement, in order to reveal if HRV can serve as a predictor to metabolic disturbance in pediatric obesity population.
Study design:
Study population and study design:
Study population The study will be performed in the Nutrition and Obesity Clinic of the Pediatric Gastroenterology Unit at "Dana Dwek" Children's Hospital.
All children and adolescents that that will be admitted to our clinic between December 2020 to December 2022 will include in the study.
Inclusion criteria: All children 10-18 with obesity, males and females, who attend the obesity clinic in the pediatric gastroenterology unit at "Dana-Dwek" children's hospital, Tel Aviv Sourasky Medical Center, will be included.
Exclusion criteria: Children with conditions that may affect HRV (e.g. congenital or acquired heart disease, other inflammatory conditions) will be excluded.
withdrawal criteria: children and parents that will refuse to participate in the telephone interview will withdrawl from the study.
Demographic data - age and gender, perinatal history, prior medication and hospitalization, sociodemographic parameters (area of living, parents' education, occupation and lifestyle) will be collected from the medical files. The obese children's perceptions of their motivation, health and social status will be ranked in 1-10 scale and documented upon admission to the clinic, and the parents' life style habits will also be documented during their first encounter. A parent will be defined as maintaining healthy lifestyle if he or she reported to maintain a healthy diet and regular exercise Clinical and metabolic evaluation Weight and height will be measured according to standardized protocols. Body mass index (BMI) percentiles are computed using age- and sex-specific BMI reference values from the World Health Organization . Body composition will be assessed using bioelectricalimpedence. Laboratory and radiologic parameters will include liver enzyme profile, lipid profile, glucose, insulin and HbA1C ,C rreactive protein (CRP) and abdominal ultrasound. MUO children and adolescent will be defined according to the recent international consensus-based definition (10). BMI Z score will be documented every 3-month and laboratory parameters will be repeated after 6 months of dietary intervention Nutritional assessment will be based on 3 days food report, including 2 week days and 1 weekend day, administered by a registered dietician at baseline visit and every 3 months.
Measurement of HRV Resting HRV will be measured by Pulse Oximeter BM2000A/Shanghai Berry Electronic Tech Co., Ltd. that is validated for this purpose and is approved by FDA. The measurement, at the patient's fingertip, takes 5 minutes. The measurement will be performed twice - at two consecutive visits at the clinic, as part as the routine follow up of the patient every 3 months.
HRV will be correlated to demographic and metabolic parameters between patients. In order to reveal whether HRV can serve as a predictor to metabolic disease progression or improvement HRV will be correlated to metabolic parameters in the same patient at two time-points.
Statistical analysis:
Epidemiologic data and patients' descriptive data available on continuous scales will be presented with medians, means and standard deviations. Categorical data will be presented as rates and percentages. Parametric tests will be applied when normality is satisfied. Regression analysis will be used to assess the impact of independent variables on the dependent variables. A p value of <0.05 will be considered significant.
Time line:
Study data analysis will be completed within 2 years.
- Conditions
- Obesity, Pediatric Obesity, Metabolic Syndrome
- Being tested
- heart rate variabilty measured by pulse oximetry
- Medical subject headings
- Obesity, Pediatric Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate variabilty measured by pulse oximetryDevice
Resting HRV will be measured by Pulse Oximeter BM2000A/Shanghai Berry Electronic Tech Co., Ltd. that is validated for this purpose and is approved by FDA. The measurement, at the patient's fingertip, takes 5 minutes. The measurement will be performed twice - at two consecutive visits at the clinic, as part as the routine follow up of the patient every 3 months.
HRV will be correlated to demographic and metabolic parameters between patients. In order to reveal whether HRV can serve as a predictor to metabolic disease progression or improvement, HRV will be correlated to metabolic parametrers in the same patient at two time-points.
| Study group | Role | What they receive |
|---|---|---|
| metabolic healthy obese | Demographic, clinical laboratory and heart rate variability assesment Receives: Device: heart rate variabilty measured by pulse oximetry | |
| metabolic unhealthy obese | Demographic, clinical laboratory and heart rate variability assesment Receives: Device: heart rate variabilty measured by pulse oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalnce of metabolic disorder in obese pediatric population
measurment of glucose , insulin and lipid profile in all th chorot
Measured: 2 years
Secondary outcomes (1)
heart rate variability
heart rate variability will be measured in all the cohort and compared between metabolicaly healthy to non healthy obese
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Jan 2021 (estimated)
- Primary completion15 Jan 2022 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- shlomi cohen, md, Principal investigator, pediatric gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694937
- Sponsor's protocol ID
- 0799-20
- Status last verified
- Jan 2021
- First submitted
- 31 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information about study subjects will remain confidential and will be managed according to the GCP requirements. The study involves de-identified data extracted from medical records. Irreversible anonymization (where it is impossible or extremely difficult to go back and uncover the identity of the patient) will be performed either by the principal investigator or by sub-investigator that has clearance to open medical records. The data file will not be sent by un-encrypted email and will not be transferred outside the medical center without prior approval on a signed data transfer agreement with the R\&D department.
Publications
1. Wang Y, Lobstein T. Worldwide trends in childhood overweight and obesity. Int J Pediatr Obes. (2006) 1:11-25. doi: 10.1080/1747 2. Zimmet P, Alberti KG, Kaufman F, Tajima N, Silink M, Arslanian S, et al. The metabolic syndrome in children and adolescents - an IDF consensus report. Pediatr Diabetes. (2007) 8:299-306. doi: 10.1111/j.1399-5448.2007. 00271.x 3. Bluher S, Schwarz P. Metabolically healthy obesity from childhood to adulthood - does weight status alone matter?Metabolism. (2014) 63:1084-92 4. Primeau V, Coderre L, Karelis AD, Brochu M, Lavoie ME, Messier V, et al. Characterizing the profile of obese patients who are metabolically healthy. Int J Obes. (2011) 35:971-81. doi: 10.1038/ijo.2010.216 5. Weiss R, Taksali SE, Dufour S, Yeckel CW, Papademetris X, Cline G, et al. The "obese insulin-sensitive" adolescent: importance of adiponectin and lipid partitioning. J Clin Endocrinol Metab. (2005) 90:3731-7. doi: 10.1210/jc.2004-2305 6. Karelis AD. Metabolically healthy but obese individuals. Lancet. 2008 372:1281-3. doi: 10.1016/S0140-6736(08)61531-7 7. Karelis AD, St-Pierre DH, Conus F, Rabasa-Lhoret R, Poehlman ET. Metabolic and body composition factors in subgroups of obesity: what do we know? J Clin Endocrinol Metab. (2004) 89:2569-75. 8. Sims EA. Are there persons who are obese, but metabolically healthy? Metabolism. (2001) 50:1499-504. 9. Bluher M. The distinction of metabolically 'healthy' from 'unhealthy' obese individuals. Curr Opin Lipidol. (2010) 21:38-43. 10. Damanhoury S, Newton AS, Rashid M, Hartling L, Byrne JLS, Ball GDC. Defining metabolically healthy obesity in children: a scoping review. Obes Rev. (2018) 19:1476-91 11. Vukovic R, Milenkovic T, Mitrovic K, Todorovic S, Plavsic L, Vukovic A, et al. Preserved insulin sensitivity predicts metabolically healthy obese phenotype in children and adolescents. Eur J Pediatr. (2015) 174:1649-55. 12. KiessW, PenkeM, Sergeyev E, NeefM, AdlerM, Gausche R, et al. Childhood obesity at the crossroads. J Pediatr Endocrinol Metab. (2015) 28:481-4. 13. Chen F, Liu J, Yan Y, Mi J, China Child and Adolescent Cardiovascular Health (CCACH) Study Group. Adolescent cardiovascular health study group. abnormal metabolic phenotypes among urban chinese children: epidemiology and the impact of DXA-measured body composition. Obesity. (2019) 27:837-44 14. Nasreddine L, Tamim H, Mailhac A, AlBuhairan FS. Prevalence and predictors of metabolically healthy obesity in adolescents: findings from the national "Jeeluna" study in Saudi-Arabia. BMC Pediatr. (2018) 18:281. 15. Roberge JB, Van Hulst A, Barnett TA, Drapeau V, Benedetti A, Tremblay A, et al. Lifestyle habits, dietary factors, and the metabolically unhealthy obese phenotype in youth. J Pediatr. (2019) 204:46-52. 16. Thayer JF, Yamamoto SS, Brosschot JF. The relationship of autonomic imbalance, heart rate variability and cardiovascular disease risk factors. Int J Cardiol 2010; 141(2): 122-131. 17.Liao D, Cai J, Rosamond WD, et al. Cardiac autonomic function and incident coronary heart disease: A populationbased case-cohort study. The ARIC study. Atherosclerosis risk in communities study. Am J Epidemiol 1997; 145(8): 696-706 18. Carnethon MR, Golden SH, Folsom AR, Haskell W, Liao D. Prospective investigation of autonomic nervous system function and the development of type 2 diabetes: The atherosclerosis risk in communities study, 1987-1998. Circulation 2003; 107(17): 2190-2195. 19. Carnethon MR, Prineas RJ, Temprosa M, et al. The association among autonomic nervous system function, incident diabetes, and intervention arm in the diabetes prevention program. Diabetes Care 2006; 29(4): 914-919 20.La Rovere MT, Bigger JT Jr, Marcus FI, Mortara A, Schwartz PJ. Baroreflex sensitivity and heart-rate variability in prediction of total cardiac mortality after myocardial infarction. ATRAMI (autonomic tone and reflexes after myocardial infarction) investigators. Lancet 1998; 351(9101): 478-484
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolically Healthy Obesity in Pediatric Population- Prevalence, Predictors and the Effect of Heart Rate Variability
- ClinicalTrials.gov ID
- NCT04694937
- Acronym / sponsor ID
- 0799-20
- Conditions
- Obesity, Pediatric Obesity, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 15 Jan 2022 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The global epidemic of childhood obesity, with the accompanying rise in the prevalence of endocrine, metabolic, and cardiovascular comorbidities in youth, represents one of the most important public health issues of the modern world. Nevertheless, a distinct subgroup of youth with obesity less prone to the development of metabolic disturbances, called "metabolically healthy obese" (MHO), has come into focus. Defining the MHO subpopulation within the youth with obesity is of high importance in order to elucidate the mechanisms protecting against the clustering of cardiometabolic risk factors, and for its clinical, preventive, and therapeutic decision-making implications. Little is known about the mechanisms of development of metabolic disturbance in pediatric obesity. Cardiac autonomic function, which can be measured non-invasively with heart rate variability (HRV), has been suggested as a potential mechanism underlying the development of metabolic syndrome and cardiovascular disease. The aims of the present study were to investigate clinical, anthropometric, and socio-demographic and lifestyle predictors of MHO in this group and to asses correlation between HRV and the metabolic syndrome progression or improvement , in order to reveal if HRV can serve as a predictor to metabolic disturbance in pediatric obesity population Materials and Methods The study will be performed in the Nutrition and Obesity Clinic of the Pediatric Gastroenterology Unit at "Dana Dwek" Children's Hospital. All children and adolescents that that will be admitted to our clinic between January 2021 to December 2022 will include in the study. sociodemographic parameters will be collected from the medical files.Blood will be drawn for complete metabolic assesment. MUO children will be defined according to the recent international definition. Resting HRV will be measured by Pulse Oximeter (BM2000A/Shanghai Berry Electronic Tech Co., Ltd.). The measurement will be performed twice - at two consecutive visits at the clinic, as part as the routine follow up of the patient every 3 months.
Detailed description
Scientific background:
The global epidemic of childhood obesity, with the accompanying rise in the prevalence of endocrine, metabolic, and cardiovascular comorbidities in youth, represents one of the most important public health issues of the modern world (1-4). The earlier occurrence and increase in the prevalence of both pediatric obesity and metabolic syndrome (MS) leads to a potential decline in life expectancy, meaning that the youth of today could be the first generation to live shorter lives than their parents (2, 4-6).
In the context of the childhood obesity pandemic, a distinct subgroup of youth with obesity less prone to the development of metabolic disturbances, called "metabolically healthy obese" (MHO), has come into focus (7, 8). Despite having obesity, MHO individuals display a "favorable" metabolic profile, with preserved insulin sensitivity, normal blood pressure and glucose regulation, normal lipids and liver enzymes, as well as a normal hormonal, inflammation, and immune profile (9-13). Although MHO status might not necessarily translate into lower mortality, and can crossover to "metabolically unhealthy obese" (MUO) phenotype during puberty, defining the MHO subpopulation within the youth with obesity is of high importance in order to elucidate the mechanisms protecting against the clustering of cardiometabolic risk factors, and for its clinical, preventive, and therapeutic decision-making implications (4, 7, 13-15).
Few studies evaluated predictors and risk factors for MUO (14-15). However, these were based on variety of definitions and criteria used for defining MHO. moreover, little is known about the mechanisms of development of metabolic disturbance in pediatric obesity. More data is needed in order to identify the parameters which have the highest ability to predict clinically significant outcomes. Cardiac autonomic function, which can be measured non-invasively with heart rate variability, has been suggested as a potential mechanism underlying the development of metabolic syndrome and cardiovascular disease (16). Autonomic dysfunction characterized by reduced heart rate variability was found to predict coronary heart disease, type 2 diabetes mellitus and of all-cause and cardiac mortality (17-20) in adult population. However, the effect of reduced heart rate variability on metabolic syndrome in pediatric population and the influence of nutritional intervention with weight reduction on heart rate variability is not known. We aimed to investigate clinical, anthropometric, and socio-demographic and lifestyle predictors of MHO in this group, to describe HRV in children with obesity, and to find correlation to the metabolic syndrome or metabolic syndrome progression or improvement, in order to reveal if HRV can serve as a predictor to metabolic disturbance in pediatric obesity population.
Study design:
Study population and study design:
Study population The study will be performed in the Nutrition and Obesity Clinic of the Pediatric Gastroenterology Unit at "Dana Dwek" Children's Hospital.
All children and adolescents that that will be admitted to our clinic between December 2020 to December 2022 will include in the study.
Inclusion criteria: All children 10-18 with obesity, males and females, who attend the obesity clinic in the pediatric gastroenterology unit at "Dana-Dwek" children's hospital, Tel Aviv Sourasky Medical Center, will be included.
Exclusion criteria: Children with conditions that may affect HRV (e.g. congenital or acquired heart disease, other inflammatory conditions) will be excluded.
withdrawal criteria: children and parents that will refuse to participate in the telephone interview will withdrawl from the study.
Demographic data - age and gender, perinatal history, prior medication and hospitalization, sociodemographic parameters (area of living, parents' education, occupation and lifestyle) will be collected from the medical files. The obese children's perceptions of their motivation, health and social status will be ranked in 1-10 scale and documented upon admission to the clinic, and the parents' life style habits will also be documented during their first encounter. A parent will be defined as maintaining healthy lifestyle if he or she reported to maintain a healthy diet and regular exercise Clinical and metabolic evaluation Weight and height will be measured according to standardized protocols. Body mass index (BMI) percentiles are computed using age- and sex-specific BMI reference values from the World Health Organization . Body composition will be assessed using bioelectricalimpedence. Laboratory and radiologic parameters will include liver enzyme profile, lipid profile, glucose, insulin and HbA1C ,C rreactive protein (CRP) and abdominal ultrasound. MUO children and adolescent will be defined according to the recent international consensus-based definition (10). BMI Z score will be documented every 3-month and laboratory parameters will be repeated after 6 months of dietary intervention Nutritional assessment will be based on 3 days food report, including 2 week days and 1 weekend day, administered by a registered dietician at baseline visit and every 3 months.
Measurement of HRV Resting HRV will be measured by Pulse Oximeter BM2000A/Shanghai Berry Electronic Tech Co., Ltd. that is validated for this purpose and is approved by FDA. The measurement, at the patient's fingertip, takes 5 minutes. The measurement will be performed twice - at two consecutive visits at the clinic, as part as the routine follow up of the patient every 3 months.
HRV will be correlated to demographic and metabolic parameters between patients. In order to reveal whether HRV can serve as a predictor to metabolic disease progression or improvement HRV will be correlated to metabolic parameters in the same patient at two time-points.
Statistical analysis:
Epidemiologic data and patients' descriptive data available on continuous scales will be presented with medians, means and standard deviations. Categorical data will be presented as rates and percentages. Parametric tests will be applied when normality is satisfied. Regression analysis will be used to assess the impact of independent variables on the dependent variables. A p value of <0.05 will be considered significant.
Time line:
Study data analysis will be completed within 2 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metabolic healthy obese | – | Device: heart rate variabilty measured by pulse oximetryDemographic, clinical laboratory and heart rate variability assesment |
| metabolic unhealthy obese | – | Device: heart rate variabilty measured by pulse oximetryDemographic, clinical laboratory and heart rate variability assesment |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The study will be performed in the Nutrition and Obesity Clinic of the Pediatric Gastroenterology Unit at "Dana Dwek" Children's Hospital. All children and adolesecnt that that will be admitted to our clinic between December 2020 to December 2022 will include in the study.
Key inclusion criteria (1 listed)
- All children 10-18 with obesity, males and females, who attend the obesity clinic in the pediatric gastroenterology unit at "Dana-Dwek" children's hospital, Tel Aviv Sourasky Medical Center, will be included
Key exclusion criteria (2 listed)
- Children with conditions that may affect HRV (e.g. congenital or acquired heart disease, other inflammatory conditions) will be excluded.
- withdrawal criteria: children and parents that will refuse to participate in the telephone interview will withdrawl from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heart rate variabilty measured by pulse oximetryResting HRV will be measured by Pulse Oximeter BM2000A/Shanghai Berry Electronic Tech Co., Ltd. that is validated for this purpose and is approved by FDA. The measurement, at the patient's fingertip, takes 5 minutes. The measurement will be performed twice - at two consecutive visits at the clinic, as part as the routine follow up of the patient every 3 months. HRV will be correlated to demographic and metabolic parameters between patients. In order to reveal whether HRV can serve as a predictor to metabolic disease progression or improvement, HRV will be correlated to metabolic parametrers in the same patient at two time-points. | Device | metabolic healthy obese, metabolic unhealthy obese |
Primary outcome
prevalnce of metabolic disorder in obese pediatric population
Time frame: 2 years
measurment of glucose , insulin and lipid profile in all th chorot
1 secondary outcome
heart rate variability
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background1. Wang Y, Lobstein T. Worldwide trends in childhood overweight and obesity. Int J Pediatr Obes. (2006) 1:11-25. doi: 10.1080/1747 2. Zimmet P, Alberti KG, Kaufman F, Tajima N, Silink M, Arslanian S, et al. The metabolic syndrome in children and adolescents - an IDF consensus report. Pediatr Diabetes. (2007) 8:299-306. doi: 10.1111/j.1399-5448.2007. 00271.x 3. Bluher S, Schwarz P. Metabolically healthy obesity from childhood to adulthood - does weight status alone matter?Metabolism. (2014) 63:1084-92 4. Primeau V, Coderre L, Karelis AD, Brochu M, Lavoie ME, Messier V, et al. Characterizing the profile of obese patients who are metabolically healthy. Int J Obes. (2011) 35:971-81. doi: 10.1038/ijo.2010.216 5. Weiss R, Taksali SE, Dufour S, Yeckel CW, Papademetris X, Cline G, et al. The "obese insulin-sensitive" adolescent: importance of adiponectin and lipid partitioning. J Clin Endocrinol Metab. (2005) 90:3731-7. doi: 10.1210/jc.2004-2305 6. Karelis AD. Metabolically healthy but obese individuals. Lancet. 2008 372:1281-3. doi: 10.1016/S0140-6736(08)61531-7 7. Karelis AD, St-Pierre DH, Conus F, Rabasa-Lhoret R, Poehlman ET. Metabolic and body composition factors in subgroups of obesity: what do we know? J Clin Endocrinol Metab. (2004) 89:2569-75. 8. Sims EA. Are there persons who are obese, but metabolically healthy? Metabolism. (2001) 50:1499-504. 9. Bluher M. The distinction of metabolically 'healthy' from 'unhealthy' obese individuals. Curr Opin Lipidol. (2010) 21:38-43. 10. Damanhoury S, Newton AS, Rashid M, Hartling L, Byrne JLS, Ball GDC. Defining metabolically healthy obesity in children: a scoping review. Obes Rev. (2018) 19:1476-91 11. Vukovic R, Milenkovic T, Mitrovic K, Todorovic S, Plavsic L, Vukovic A, et al. Preserved insulin sensitivity predicts metabolically healthy obese phenotype in children and adolescents. Eur J Pediatr. (2015) 174:1649-55. 12. KiessW, PenkeM, Sergeyev E, NeefM, AdlerM, Gausche R, et al. Childhood obesity at the crossroads. J Pediatr Endocrinol Metab. (2015) 28:481-4. 13. Chen F, Liu J, Yan Y, Mi J, China Child and Adolescent Cardiovascular Health (CCACH) Study Group. Adolescent cardiovascular health study group. abnormal metabolic phenotypes among urban chinese children: epidemiology and the impact of DXA-measured body composition. Obesity. (2019) 27:837-44 14. Nasreddine L, Tamim H, Mailhac A, AlBuhairan FS. Prevalence and predictors of metabolically healthy obesity in adolescents: findings from the national "Jeeluna" study in Saudi-Arabia. BMC Pediatr. (2018) 18:281. 15. Roberge JB, Van Hulst A, Barnett TA, Drapeau V, Benedetti A, Tremblay A, et al. Lifestyle habits, dietary factors, and the metabolically unhealthy obese phenotype in youth. J Pediatr. (2019) 204:46-52. 16. Thayer JF, Yamamoto SS, Brosschot JF. The relationship of autonomic imbalance, heart rate variability and cardiovascular disease risk factors. Int J Cardiol 2010; 141(2): 122-131. 17.Liao D, Cai J, Rosamond WD, et al. Cardiac autonomic function and incident coronary heart disease: A populationbased case-cohort study. The ARIC study. Atherosclerosis risk in communities study. Am J Epidemiol 1997; 145(8): 696-706 18. Carnethon MR, Golden SH, Folsom AR, Haskell W, Liao D. Prospective investigation of autonomic nervous system function and the development of type 2 diabetes: The atherosclerosis risk in communities study, 1987-1998. Circulation 2003; 107(17): 2190-2195. 19. Carnethon MR, Prineas RJ, Temprosa M, et al. The association among autonomic nervous system function, incident diabetes, and intervention arm in the diabetes prevention program. Diabetes Care 2006; 29(4): 914-919 20.La Rovere MT, Bigger JT Jr, Marcus FI, Mortara A, Schwartz PJ. Baroreflex sensitivity and heart-rate variability in prediction of total cardiac mortality after myocardial infarction. ATRAMI (autonomic tone and reflexes after myocardial infarction) investigators. Lancet 1998; 351(9101): 478-484
- Individual participant dataSharing planned: No. Information about study subjects will remain confidential and will be managed according to the GCP requirements. The study involves de-identified data extracted from medical records. Irreversible anonymization (where it is impossible or extremely difficult to go back and uncover the identity of the patient) will be performed either by the principal investigator or by sub-investigator that has clearance to open medical records. The data file will not be sent by un-encrypted email and will not be transferred outside the medical center without prior approval on a signed data transfer agreement with the R\&D department.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shlomi cohen, md principal investigator
pediatric gastroenterology
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Pediatric Obesity, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hadar lev, md (00972527360713, hadarlev6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalnce of metabolic disorder in obese pediatric population (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.