Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children

January 14, 2014 updated by: Tel-Aviv Sourasky Medical Center

SDB has been identified as an important risk factor for insulin resistance and the metabolic syndrome.

In a recent study in patients with SDB and T2DM it was shown that CPAP therapy can lead to improvements in postprandial glucose levels and in glycosylated hemoglobin levels (HbA1c).

In children, there are only 3 studies that have examined the relations between SDB, obesity and the metabolic syndrome.

In order to further understand the relative contribution of SDB to the development of impaired glucose homeostasis and metabolic abnormalities we aim to investigate the prevalence and severity of SDB in children with T2DM compared to obese children without T2DM. The investigators hypothesize that SDB will be more prevalent and more severe among obese children with T2DM compared with the general obese pediatric population.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

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

  • Israel
      • Tel-Aviv, Israel
        • Recruiting
        • Sourasky Medical Center

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

6 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children 6-20 years old

Description

Inclusion Criteria:

  • diagnosed with T2DM
  • obese

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort
Obesity
T2DM
Children 6-20 years old diagnosed with T2DM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigate the prevalence and severity of SDB among children with T2DM compared to its prevalence in non-diabetic obese children.
Time Frame: In 6 months
In 6 months
To measure markers of inflammation and oxidative stress known to be associated with cardiovascular morbidity in children with T2DM and SDB compared to non-diabetic obese children.
Time Frame: In 6 months
In 6 months
To examine changes in metabolic measures and markers of inflammation and oxidative stress in response to treatment for SDB (adenotonsillectomy) in children with T2DM compared to obese children without T2DM.
Time Frame: In 6 months
In 6 months

Collaborators and Investigators

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

Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

Schneider Children's Hospital

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

June 1, 2007

Primary Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 15, 2014

Study Record Updates

Last Update Posted (Estimate)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-14-RT-07-066-CTIL

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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