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

NCT03316989 | Completed

• 1 other identifier: SHEBA-09-7461-OH-CTIL
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome Obesity

Outcome Measures

Primary Outcomes (1)

• Melatonin levels

  Melatonin levels in the saliva during the evening and night

  8 hours

Study Arms (3)

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

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children and adolescents with obesity and normal weight

You may qualify if:

• obese children
• normal weight children

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head department of Pediatric Endocrinology

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: June 29, 2010
• Primary Completion: May 30, 2013
• Study Completion: May 30, 2013
• Last Updated: October 23, 2017

Record last verified: 2017-10