Type 2 DiabetesNCT00901472
Sleep Disordered Breathing and Diabetes
An observational study of Type 2 Diabetes and Obstructive Sleep Apnea, run by University of Chicago at 1 site in United States.
Trial summary
The hypothesis of this study is: sleep disordered breathing (SDB), specifically, obstructive sleep apnea, is associated with poorer glucose in the existing type 2 diabetic condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Obstructive Sleep Apnea
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult female and male patients with type 2 diabetes who are followed by University of Chicago physicians in the endocrinology or primary care clinic will self-identify themselves for participation in response to flyers posted at the check-in desk.
Who may be able to join
- adult female and male patients with type 2 diabetes who are followed by University of Chicago physicians
Who cannot join
- patients with the diagnosis of type 1 diabetes (DM); newly diagnosed Type 2 DM patients
- patients with the diagnosis of OSA using CPAP for either 4 or more hours per night or 5 nights per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Disordered Breathing and Blood Glucose Control in Type 2 Diabetes
The hypothesis of this study is: sleep disordered breathing (SDB), specifically, obstructive sleep apnea, is associated with poorer glucose in the existing type 2 diabetic condition.
In an exploration of this hypothesis, the investigators hope to provide evidence linking SDB to increased severity of disease in the type 2 diabetic patient. By doing so, the investigators ultimately seek to support investigating the use of SDB interventions as an additional method of care in the treatment of type 2 diabetes.
- Conditions
- Type 2 Diabetes, Obstructive Sleep Apnea
- Keywords
- Type 2 diabetes,, obstructive sleep apnea
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Apnea, Obstructive
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 |
|---|---|---|
| Stable type 2 Diabetes (ST2D) | Adults with Type 2 diabetes who receive medical care at the University of Chicago |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in glucose tolerance
Measured: Day 1 to day 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startFeb 2007
- Primary completionNov 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eve Van Cauter, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901472
- Sponsor's protocol ID
- #14903B
- Status last verified
- Sep 2013
- First submitted
- 11 May 2009
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing and Blood Glucose Control in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00901472
- Acronym / sponsor ID
- #14903B
- Conditions
- Type 2 Diabetes, Obstructive Sleep Apnea
- Keywords
- Type 2 diabetes,, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 May 2009 (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.
The hypothesis of this study is: sleep disordered breathing (SDB), specifically, obstructive sleep apnea, is associated with poorer glucose in the existing type 2 diabetic condition.
In an exploration of this hypothesis, the investigators hope to provide evidence linking SDB to increased severity of disease in the type 2 diabetic patient. By doing so, the investigators ultimately seek to support investigating the use of SDB interventions as an additional method of care in the treatment of type 2 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable type 2 Diabetes (ST2D) | – | –Adults with Type 2 diabetes who receive medical care at the University of Chicago |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female and male patients with type 2 diabetes who are followed by University of Chicago physicians in the endocrinology or primary care clinic will self-identify themselves for participation in response to flyers posted at the check-in desk.
Key inclusion criteria (1 listed)
- adult female and male patients with type 2 diabetes who are followed by University of Chicago physicians
Key exclusion criteria (2 listed)
- patients with the diagnosis of type 1 diabetes (DM); newly diagnosed Type 2 DM patients
- patients with the diagnosis of OSA using CPAP for either 4 or more hours per night or 5 nights per week
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
Improvement in glucose tolerance
Time frame: Day 1 to day 10.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
Eve Van Cauter, PhD principal investigator
University of Chicago
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 Type 2 Diabetes and Obstructive Sleep Apnea, run by University of Chicago at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 5 Sep 2013. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in glucose tolerance (time frame: Day 1 to day 10.). 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 5 Sep 2013.