Diabetes MellitusNCT03314467
Role of Obstructive Sleep Apnea Syndrome in the Occurrence of Diabetic Retinopathy in Type 2 Diabetes.
An observational study of Diabetes Mellitus and Obstructive Sleep Apnea, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors for developing DR are diabetes duration, glycemic control, and hypertension . The prevalence ranges from 17 to 61% according to the diabetes duration . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Obstructive Sleep Apnea
- What is being tested?
- polysomnography
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Oct 2017to 30 Jun 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a diagnosis of diabetes type I or type II who went to a ocular screening visit to assess ocular complications associated with diabetes are asked to undergo an in-lab polysomnography..
Who may be able to join
- presence of diabetic type II
- able to undergo an in-lab polysomnography
Who cannot join
- known presence of obstructive sleep apnea and treated by CPAP
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors for developing DR are diabetes duration, glycemic control, and hypertension . The prevalence ranges from 17 to 61% according to the diabetes duration .
Obstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population, reaching a prevalence of 23-48% .
Few is known about the exact role of OSAS in the development of DR. A recent study has shown that OSAS is an independent predictor for the progression to pre-/proliferative DR. The purpose of the present study is to assess if the presence of OSA in diabetic patients is a predictive factor for DR occurrence.
Read the detailed description
Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors for developing DR are diabetes duration, glycemic control, and hypertension. The prevalence ranges from 17 to 61% according to the diabetes duration.
Obstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population, reaching a prevalence of 23-48%.
Few is known about the exact role of OSAS in the development of DR. A recent study has shown that OSAS is an independent predictor for the progression to pre-/proliferative DR. The purpose of the present study is to assess if the presence of OSA in diabetic patients is a predictive factor for DR occurrence.
- Conditions
- Diabetes Mellitus, Obstructive Sleep Apnea
- Being tested
- polysomnography
- Keywords
- diabetic retinopathy, diabetes, arterial hypertension, obstructive sleep apnea syndrome
- Medical subject headings
- Diabetes Mellitus, Sleep Apnea, Obstructive, Diabetic Retinopathy, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyDiagnostic test
Also called arterial tension, blood test
- classical polysomnography
- non invasive measurement of blood pressure
- blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes
| Study group | Role | What they receive |
|---|---|---|
| Cases DR | diabetic patients with diabetic retinopathy (DR) Receives: Diagnostic Test: polysomnography | |
| Cases other | diabetic patiens with other/multiple ocular disorder(s) Receives: Diagnostic Test: polysomnography | |
| Control | diabetic patients without ocular abnormalities Receives: Diagnostic Test: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of obstructive sleep apnea in diabetic patients is a predictive factor for diabetic retinopathy occurence
obstructive sleep apnea is defined as apnea-hypopnea index > 15 on polysomnography
Measured: 1 month
Secondary outcomes (1)
Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start6 Oct 2017
- Primary completion30 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Marie Bruyneel, MD, PhD, Principal investigator, Centre hospitalier universitaire St Pièrre - Pneumologie/Labo du sommeil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314467
- Sponsor's protocol ID
- BE76201733442
- Status last verified
- Sep 2021
- First submitted
- 16 Oct 2017
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altaf QA, Dodson P, Ali A, Raymond NT, Wharton H, Fellows H, Hampshire-Bancroft R, Shah M, Shepherd E, Miah J, Barnett AH, Tahrani AA. Obstructive Sleep Apnea and Retinopathy in Patients with Type 2 Diabetes. A Longitudinal Study. Am J Respir Crit Care Med. 2017 Oct 1;196(7):892-900. doi: 10.1164/rccm.201701-0175OC.
PubMed 28594570Mok Y, Tan CW, Wong HS, How CH, Tan KL, Hsu PP. Obstructive sleep apnoea and Type 2 diabetes mellitus: are they connected? Singapore Med J. 2017 Apr;58(4):179-183. doi: 10.11622/smedj.2017027.
PubMed 28429032Vujosevic S, Midena E. Diabetic Retinopathy in Italy: Epidemiology Data and Telemedicine Screening Programs. J Diabetes Res. 2016;2016:3627465. doi: 10.1155/2016/3627465. Epub 2016 Nov 21.
PubMed 27990441Zhou Y, Zhang Y, Shi K, Wang C. Body mass index and risk of diabetic retinopathy: A meta-analysis and systematic review. Medicine (Baltimore). 2017 Jun;96(22):e6754. doi: 10.1097/MD.0000000000006754.
PubMed 28562529
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Obstructive Sleep Apnea Syndrome in the Occurrence of Diabetic Retinopathy in Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT03314467
- Acronym / sponsor ID
- BE76201733442
- Conditions
- Diabetes Mellitus, Obstructive Sleep Apnea
- Keywords
- diabetic retinopathy, diabetes, arterial hypertension, obstructive sleep apnea syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Oct 2017 (actual)
- 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.
Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors for developing DR are diabetes duration, glycemic control, and hypertension . The prevalence ranges from 17 to 61% according to the diabetes duration .
Obstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population, reaching a prevalence of 23-48% .
Few is known about the exact role of OSAS in the development of DR. A recent study has shown that OSAS is an independent predictor for the progression to pre-/proliferative DR. The purpose of the present study is to assess if the presence of OSA in diabetic patients is a predictive factor for DR occurrence.
Detailed description
Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors for developing DR are diabetes duration, glycemic control, and hypertension. The prevalence ranges from 17 to 61% according to the diabetes duration.
Obstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population, reaching a prevalence of 23-48%.
Few is known about the exact role of OSAS in the development of DR. A recent study has shown that OSAS is an independent predictor for the progression to pre-/proliferative DR. The purpose of the present study is to assess if the presence of OSA in diabetic patients is a predictive factor for DR occurrence.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases DR | – | Diagnostic Test: polysomnographydiabetic patients with diabetic retinopathy (DR) |
| Cases other | – | Diagnostic Test: polysomnographydiabetic patiens with other/multiple ocular disorder(s) |
| Control | – | Diagnostic Test: polysomnographydiabetic patients without ocular abnormalities |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a diagnosis of diabetes type I or type II who went to a ocular screening visit to assess ocular complications associated with diabetes are asked to undergo an in-lab polysomnography..
Key inclusion criteria (2 listed)
- presence of diabetic type II
- able to undergo an in-lab polysomnography
Key exclusion criteria (1 listed)
- known presence of obstructive sleep apnea and treated by CPAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polysomnographyAlso: arterial tension, blood test* classical polysomnography * non invasive measurement of blood pressure * blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes | Diagnostic test | Cases DR, Cases other, Control |
Primary outcome
Presence of obstructive sleep apnea in diabetic patients is a predictive factor for diabetic retinopathy occurence
Time frame: 1 month
obstructive sleep apnea is defined as apnea-hypopnea index > 15 on polysomnography
1 secondary outcome
Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy
Time frame: 1 month
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 2 Sep 2021.
- Background: PubMed 28594570Altaf QA, Dodson P, Ali A, Raymond NT, Wharton H, Fellows H, Hampshire-Bancroft R, Shah M, Shepherd E, Miah J, Barnett AH, Tahrani AA. Obstructive Sleep Apnea and Retinopathy in Patients with Type 2 Diabetes. A Longitudinal Study. Am J Respir Crit Care Med. 2017 Oct 1;196(7):892-900. doi: 10.1164/rccm.201701-0175OC.
- Background: PubMed 28429032Mok Y, Tan CW, Wong HS, How CH, Tan KL, Hsu PP. Obstructive sleep apnoea and Type 2 diabetes mellitus: are they connected? Singapore Med J. 2017 Apr;58(4):179-183. doi: 10.11622/smedj.2017027.
- Background: PubMed 27990441Vujosevic S, Midena E. Diabetic Retinopathy in Italy: Epidemiology Data and Telemedicine Screening Programs. J Diabetes Res. 2016;2016:3627465. doi: 10.1155/2016/3627465. Epub 2016 Nov 21.
- Background: PubMed 28562529Zhou Y, Zhang Y, Shi K, Wang C. Body mass index and risk of diabetic retinopathy: A meta-analysis and systematic review. Medicine (Baltimore). 2017 Jun;96(22):e6754. doi: 10.1097/MD.0000000000006754.
- Individual participant dataSharing planned: No
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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.
Marie Bruyneel, MD, PhD principal investigator
Centre hospitalier universitaire St Pièrre - Pneumologie/Labo du sommeil
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 Diabetes Mellitus and Obstructive Sleep Apnea, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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: finished, as of the sponsor's last update on 2 Sep 2021. 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 Belgium. 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?
Presence of obstructive sleep apnea in diabetic patients is a predictive factor for diabetic retinopathy occurence (time frame: 1 month). 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 NCT03314467, which also lists 4 linked publications.
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 2 Sep 2021.