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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02037100
Other study ID # TASMC-14-RT-07-066-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received January 13, 2014
Last updated January 14, 2014
Start date June 2007

Study information

Verified date January 2014
Source Tel-Aviv Sourasky Medical Center
Contact Riva Tauman, Dr.
Email tauman@tlvmc.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 20 Years
Eligibility Inclusion Criteria:

- diagnosed with T2DM

- obese

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Sourasky Medical Center Tel-Aviv

Sponsors (2)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center Schneider Children's Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Investigate the prevalence and severity of SDB among children with T2DM compared to its prevalence in non-diabetic obese children. In 6 months No
Primary 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. In 6 months No
Primary 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. In 6 months No
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