Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children

Obesity Clinical Trial

Official title:

Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02037100
• Other study ID #: TASMC-14-RT-07-066-CTIL
• 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. 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

• Obesity
• SDB
• T2DM

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