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CompletedNCT03316989Updated Oct 23, 2017

Melatonin Levels and the Relation to Obesity and the Metabolic Syndrome in Children and Adolescents

An observational study in Metabolic Syndrome Obesity, sponsored by Sheba Medical Center. Completed. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-23.

Sponsored by Sheba Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
12 Years to 18 Years
Sex
All
01

Study summary

Background: Melatonin is a neurohormone that regulates the circadian rhythm by translating photoperiodic information from the eyes to the brain.

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.

Read the detailed description

Background: Melatonin is a neurohormone that regulates the circadian rhythm by translating photoperiodic information from the eyes to the brain. MTNR1B , is one of melatonin receptors which is expressed in the retina, in the brain and in pancreatic tissue. In Genome Wide Association studies a SNP in the intronic variant in MTNR1B was found to be to in association with elevated fasting plasma glucose and with increased risk of T2DM among lean and obese adults and children.

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.

02

Conditions studied

  • Metabolic Syndrome Obesity
03

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

children and adolescents with obesity and normal weight

Inclusion criteria

  • obese children
  • normal weight children

Exclusion criteria

Exclusion Criteria:

  • genetic diseases
  • medication that may affect melatonin secretion
  • sleep inducing medication
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (actual)

Groups and cohorts

  • obese children

    Children and adolescents with BMI according to the CDC greater that 95%ile

  • normal weight

    Children and adolescents with BMI according to the CDC less than the 85%ile

  • obese with the MetS

    obese children with metabolic syndrome compared to obese children with out the MetS and normal weight children

05

What researchers measure

Primary outcomes

  1. Melatonin levels

    Melatonin levels in the saliva during the evening and night

    Time frame: 8 hours

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03316989
Lead sponsor
Sheba Medical Center
Responsible party
Dr. Orit Hamiel (Head department of Pediatric Endocrinology, Sheba Medical Center) — Principal investigator
First posted
Oct 23, 2017
Start date
Jun 29, 2010
Primary completion
May 30, 2013
Completion
May 30, 2013
Last update
Oct 23, 2017

Oversight

Data monitoring committee
No
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