Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children

NCT ID: NCT02037100

Last Updated: 2014-01-15

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

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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SDB T2DM Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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T2DM

Children 6-20 years old diagnosed with T2DM

No interventions assigned to this group

Obesity

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* diagnosed with T2DM
* obese

Exclusion Criteria

\-
Minimum Eligible Age

6 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Schneider Children's Hospital

OTHER

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Riva Tauman, Dr.

Role: CONTACT

Other Identifiers

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TASMC-14-RT-07-066-CTIL

Identifier Type: -

Identifier Source: org_study_id

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