Melatonin Levels and the Relation to Obesity and the Metabolic Syndrome in Children and Adolescents
NCT ID: NCT03316989
Last Updated: 2017-10-23
Study Results
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Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2010-06-29
2013-05-30
Brief Summary
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Working hypothesis and aims: There is a possible link between circadian rhythm regulation and glucose homeostasis through melatonin pathways. We aim to examine the relation between melatonin levels and degree of obesity , in children and adolescents in different pubertal stages.
Methods: The study group will include 24 children and adolescents in various stages of pubertal development. Participants will be categorized into 3 groups: 1) normal-weight, 2) obese subjects with metabolic syndrome, 3) obese without metabolic syndrome. Melatonin levels will be measured using saliva during the night.
Expected results: We expect to find a relation between melatonin levels to the metrics of metabolic syndrome, sleep duration, number of television viewing hours and sense of depression.
Importance: Childhood obesity is recognized as a major medical and public health problem and is strongly associated with many serious medical complications including the metabolic syndrome and Type 2 diabetes (T2DM). It is important to understand mechanisms involved in the development of obesity and hyperinsulinemia.
Probable implications to Medicine: Foreseeing a connection between melatonin levels and the degree of obesity and metabolic syndrome in children and adolescents, we would recommend addressing duration of sleep while treating obesity.
Detailed Description
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Working hypothesis and aims: There is a possible link between circadian rhythm regulation and glucose homeostasis through melatonin pathways. We aim to examine the relation between melatonin levels and degree of obesity and the metabolic syndrome, in children and adolescents in different pubertal stages.
Methods: The study group will include twenty-four children and adolescents in various stages of pubertal development. Participants will be categorized into three groups: 1) normal-weight, 2) obese subjects with metabolic syndrome, 3) obese without metabolic syndrome. Melatonin levels will be measured using saliva during the night. Each child will be measured for height, weight, waist circumference and blood pressure. Fasting insulin, glucose and lipid profile will be taken. Each child will fill out questionnaires about depression, sleep quality and television usage.
Expected results: We expect to find a relation between melatonin levels to the metrics of metabolic syndrome, sleep duration, number of television viewing hours and sense of depression. We expect to find lower levels of melatonin in the group of obese children with metabolic syndrome during night time. We expect that children with lower levels of melatonin should report on fewer hours of sleep, more hours of watching television and feeling more depressed.
Importance: Childhood obesity is recognized as a major medical and public health problem and is strongly associated with many serious medical complications including the metabolic syndrome and Type 2 diabetes (T2DM). It is important to understand mechanisms involved in the development of obesity and hyperinsulinemia.
Probable implications to Medicine: Foreseeing a connection between melatonin levels and the degree of obesity and metabolic syndrome in children and adolescents, we would recommend addressing duration of sleep while treating obesity.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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obese children
Children and adolescents with BMI according to the CDC greater that 95%ile
No interventions assigned to this group
normal weight
Children and adolescents with BMI according to the CDC less than the 85%ile
No interventions assigned to this group
obese with the MetS
obese children with metabolic syndrome compared to obese children with out the MetS and normal weight children
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* normal weight children
Exclusion Criteria
* medication that may affect melatonin secretion
* sleep inducing medication
12 Years
18 Years
ALL
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Orit Hamiel
Head department of Pediatric Endocrinology
Other Identifiers
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SHEBA-09-7461-OH-CTIL
Identifier Type: -
Identifier Source: org_study_id