ObesityDiabetesleepNCT01343446
Sleep Impairment and Coping Style in Diabetes
An observational study of Obesity and Sleep Disorders, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
To examine the effect of sleep impairment on coping style of patients with diabetes Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Sleep Disorders, Coping Skills
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2011to Mar 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Followed-up in Cerrahpasa Clinics of Diabetes Patients with diabetes Patients with/without diabetic complication Patients suffer from sleep impairment
Who may be able to join
- Patients with diabetes longer than 6 months
Who cannot join
- Complications as a congestive heart failure, chronic renal failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diabetes and Metabolism Outpatients Clinic of Cerrahpasa School of Medicine
Istanbul, 34098
About this study
Official title: Sleep Impairment Can Influence The Coping Style Of Patients With Diabetes
To examine the effect of sleep impairment on coping style of patients with diabetes
Read the detailed description
Abstract Objective: To examine the effect of sleep impairment on coping style of patients with diabetes Research Design and Methods: A total of 105 patients (40 male, 65 female) with diabetes mellitus were recruited from outpatient diabetic clinics in 2011 February. All patients were asked to fill the sociodemographic inquiry, Epworth Sleepiness Scale and Coping Style Inventory.
- Conditions
- Obesity, Sleep Disorders, Coping Skills
- Keywords
- Sleep impairment, Coping Style, Diabetes Mellitus
- Medical subject headings
- Obesity, Sleep Wake Disorders, Diabetes Mellitus
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 |
|---|---|---|
| Patients with Diabetes | Patients with diabetes suffer from sleep impairment or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping style of Patients with Diabetes suffer from Sleep Disorder
Patients with diabetes had filled the Epworth Sleepiness Scale and Coping styles ınventory
Measured: Up to 1 week (Patients at follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Investigators
- Murat Emül, Assoc.Prof., Study director, Department of Psychiatry, Cerrahpasa School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343446
- Sponsor's protocol ID
- Cer-Met-A2
- Acronym
- Diabetesleep
- Status last verified
- Apr 2011
- First submitted
- 26 Apr 2011
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Luyckx K, Seiffge-Krenke I, Hampson SE. Glycemic control, coping, and internalizing and externalizing symptoms in adolescents with type 1 diabetes: a cross-lagged longitudinal approach. Diabetes Care. 2010 Jul;33(7):1424-9. doi: 10.2337/dc09-2017. Epub 2010 Mar 31.
PubMed 20357383
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Impairment Can Influence The Coping Style Of Patients With Diabetes
- ClinicalTrials.gov ID
- NCT01343446
- Acronym / sponsor ID
- Diabetesleep / Cer-Met-A2
- Conditions
- Obesity, Sleep Disorders, Coping Skills
- Keywords
- Sleep impairment, Coping Style, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Apr 2011 (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.
To examine the effect of sleep impairment on coping style of patients with diabetes
Detailed description
Abstract Objective: To examine the effect of sleep impairment on coping style of patients with diabetes Research Design and Methods: A total of 105 patients (40 male, 65 female) with diabetes mellitus were recruited from outpatient diabetic clinics in 2011 February. All patients were asked to fill the sociodemographic inquiry, Epworth Sleepiness Scale and Coping Style Inventory.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Diabetes | – | –Patients with diabetes suffer from sleep impairment or not |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Followed-up in Cerrahpasa Clinics of Diabetes Patients with diabetes Patients with/without diabetic complication Patients suffer from sleep impairment
Key inclusion criteria (1 listed)
- Patients with diabetes longer than 6 months
Key exclusion criteria (1 listed)
- Complications as a congestive heart failure, chronic renal failure
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
Coping style of Patients with Diabetes suffer from Sleep Disorder
Time frame: Up to 1 week (Patients at follow-up)
Patients with diabetes had filled the Epworth Sleepiness Scale and Coping styles ınventory
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 28 Apr 2011.
- Results publication: PubMed 20357383Luyckx K, Seiffge-Krenke I, Hampson SE. Glycemic control, coping, and internalizing and externalizing symptoms in adolescents with type 1 diabetes: a cross-lagged longitudinal approach. Diabetes Care. 2010 Jul;33(7):1424-9. doi: 10.2337/dc09-2017. Epub 2010 Mar 31.
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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.
Murat Emül, Assoc.Prof. study director
Department of Psychiatry, Cerrahpasa School of Medicine
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 Obesity and Sleep Disorders, run by Istanbul University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 28 Apr 2011. 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 Turkey (Türkiye). 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?
Coping style of Patients with Diabetes suffer from Sleep Disorder (time frame: Up to 1 week (Patients at follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01343446, which also lists 1 linked publication.
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 28 Apr 2011.