SDBNCT02037100
Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children
An observational study of SDB and T2DM, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children 6-20 years old
Who may be able to join
- diagnosed with T2DM
- obese
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Riva Tauman, Dr. contact
About this study
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).
Read more
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.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T2DM | Children 6-20 years old diagnosed with T2DM | |
| Obesity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the prevalence and severity of SDB among children with T2DM compared to its prevalence in non-diabetic obese children.
Measured: 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.
Measured: 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.
Measured: In 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJun 2007
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SDBStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Schneider Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037100
- Sponsor's protocol ID
- TASMC-14-RT-07-066-CTIL
- Status last verified
- Jan 2014
- First submitted
- 13 Jan 2014
- Last updated
- 15 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children
- ClinicalTrials.gov ID
- NCT02037100
- Acronym / sponsor ID
- TASMC-14-RT-07-066-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Schneider Children's Hospital
- Study start
- Jun 2007
- Primary completion
- Sep 2014 (estimated)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM | – | –Children 6-20 years old diagnosed with T2DM |
| Obesity | – | – |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children 6-20 years old
Key inclusion criteria (2 listed)
- diagnosed with T2DM
- obese
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riva Tauman, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SDB and T2DM, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Riva Tauman, Dr. (tauman@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2014.