Hormonal and Metabolic Consequences of Sleep Disorders in Young Obese Patients (SOM)

January 20, 2009 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
There is a well-documented relationship between short sleep duration and high body mass index (BMI). The mechanism linking short sleep duration and weight gain is unknown. Current studies in healthy young volunteers have shown that experimental sleep restriction is associated with dysregulation of the neuroendocrine control of appetite and with alterations in glucose metabolism. The goal of our study is to determine the metabolic and hormonal modifications induced by chronic sleep curtailment in obese adolescents and young adults and to observe if short sleep is a negative prognostic factor in their weight evolution.

Study Overview

Status

Unknown

Conditions

Detailed Description

The main purpose of the study is investigate whether the concentrations of 2 hormones that regulate appetite (leptin, ghrelin), cytokines (TNF-a, IL-6) and CRP are modified in obese adolescents and young adults who had sleep disorders in comparison to obese adolescents and young adults who sleep longer.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of the output clinics in the endocrinology and pediatric endocrinology departments at the university hospital.

Description

Inclusion Criteria:

  • 13-25 years old
  • BMI > 30 kg/m2 (If adolescents aged under 18 years: BMI equivalent to a BMI for age and sex to a BMI of 30, according to the Cole et al. obesity criteria).

Exclusion Criteria:

  • Infection
  • Liver disease
  • Chronic inflammatory disease
  • Endocrine disease
  • Use of drugs that alter the sensitivity of insulin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
1
Obese adolescent and young adult with sleep disorder
2
Obese adolescent and young adult without sleep disorder
3
Lean adolescent and young adult with sleep disorder

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Veronique Beauloye, PhD, Cliniques Universitaires Saint-Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

July 15, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B40320084032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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