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

Sponsor

Sheba Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03316989

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Obesity

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.

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Melatonin Levels and Obesity

Actual Study Start Date :

Jun 29, 2010

Actual Primary Completion Date :

May 30, 2013

Actual Study Completion Date :

May 30, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Melatonin levels [8 hours]
Melatonin levels in the saliva during the evening and night

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

obese children
normal weight children

Exclusion Criteria:

genetic diseases
medication that may affect melatonin secretion
sleep inducing medication

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Orit Hamiel, Head department of Pediatric Endocrinology, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT03316989

Other Study ID Numbers:

SHEBA-09-7461-OH-CTIL

First Posted:

Oct 23, 2017

Last Update Posted:

Oct 23, 2017

Last Verified:

Oct 1, 2017

Additional relevant MeSH terms:

Obesity

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of Oct 23, 2017