Chronobiology and Childhood Obesity in a Mediterranean Spanish Population

NCT ID: NCT02895282

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main objective is to investigate chronobiological aspects of childhood obesity studying the potential relationship between meal patterns and circadian rhythmicity in a cross-sectional sample of obese, overweight and normal weight children/adolescent.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Childhood obesity has more than doubled in children and tripled in adolescents in the past 30 y. As consequence, increasingly children and adolescents suffer from elevated blood pressure, impaired glucose tolerance, hyperinsulinemia, dyslipidemia. Obesity has a multifactorial etiology since there are potentially numerous contributors to its development and progression. Chronobiology, the science that studies periodic (cyclic) changes in living organisms, has been recently proposed as a new and promising topic to investigate. Alterations of circadian (24 h oscillations) system may contribute to obesity and its complications development such as high blood pressure, insulin resistance, altered fasting lipid profile. Conversely, in a vicious manner, obesity has been regarded as a fault in the circadian system explainable by the association with imbalances and fluctuations of hormones/genes expressions rhythms under the influence of body weight changes.

Thus, the study will examine changes in circadian rhythmicity over a week period. The primary end point will be to evaluate differences between obese/overweight and non-obese children in chronotypes and the responses of these parameters to meal patterns. In particular, non-invasive measures that are well-established determinants of chronotypes will form the core endpoints for the study. Well designed and age-appropriate questionnaires will provide further information in order to study correlations with eating, sleeping and sedentary/active behaviors.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Chronobiology Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age: 8-12 years of age
* Children from schools in the region of Murcia (Spain) who enter voluntarily

Exclusion Criteria

* Children who take melatonin or sleep drugs
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

PROF. MARTA GARAULET AZA

Full professor of University of Murcia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marta Garaulet, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Murcia. Spain

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chronobiology laboratory, Department of Physiology

Murcia, , Spain

Site Status

University of Murcia

Murcia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Qian J, Martinez-Lozano N, Tvarijonaviciute A, Rios R, Scheer FAJL, Garaulet M. Blunted rest-activity rhythms link to higher body mass index and inflammatory markers in children. Sleep. 2021 May 14;44(5):zsaa256. doi: 10.1093/sleep/zsaa256.

Reference Type DERIVED
PMID: 33249510 (View on PubMed)

Barraco GM, Martinez-Lozano N, Vales-Villamarin C, Del Carmen Blaya M, Rios R, Madrid JA, Fardy P, Garaulet M. Circadian health differs between boys and girls as assessed by non-invasive tools in school-aged children. Clin Nutr. 2019 Apr;38(2):774-781. doi: 10.1016/j.clnu.2018.03.001. Epub 2018 Mar 21.

Reference Type DERIVED
PMID: 29609867 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAF2014-52480-R

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sarcopenic Obesity as a Risk of Premature Aging
NCT05443711 ACTIVE_NOT_RECRUITING
Leipzig Childhood Obesity Study
NCT04491344 RECRUITING