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Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children

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ClinicalTrials.gov Identifier: NCT02037100
Recruitment Status : Unknown
Verified January 2014 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : January 15, 2014
Last Update Posted : January 15, 2014
Sponsor:
Collaborator:
Schneider Children's Hospital
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:

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.


Condition or disease
SDB T2DM Obesity

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children
Study Start Date : June 2007
Estimated Primary Completion Date : September 2014

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



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children 6-20 years old
Criteria

Inclusion Criteria:

  • diagnosed with T2DM
  • obese

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037100


Contacts
Contact: Riva Tauman, Dr. tauman@tlvmc.gov.il

Locations
Israel
Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Schneider Children's Hospital

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02037100     History of Changes
Other Study ID Numbers: TASMC-14-RT-07-066-CTIL
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: January 15, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases