Diabetic Complications and Obstructive Sleep ApneaDMOSNCT04646941
Diabetic Complications and Obstructive Sleep Apnea
An observational study of Diabetic Complications and Obstructive Sleep Apnea, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To follow up the progress of chronic complications in T2DM patients who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Complications and Obstructive Sleep Apnea
- What is being tested?
- regular treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2020to 31 Jan 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Type 2 diabetes
Who may be able to join
- Type 2 diabetes
- Age：18-80
Who cannot join
- Patients with non type 2 diabetes mellitus
- Preparation for pregnancy
- Lactation patients
- Patients with uncontrolled thyroid disease
- Patients with severe cardiovascular disease
- Patients with severe hepatic and renal insufficiency
Show all 10Show fewer
- Patients with oral and maxillofacial malformations and upper respiratory tract malformations
- Patients with pulmonary infection or COPD
- Patients who are not willing to accept the questionnaire survey
- Unable to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Xiamen university
Xiamen, Fujian, 361003
Changqin Liu, MD, +86-133 7698 6106, liuchangqin@xmu.edu.cn
About this study
Official title: Diabetic Complications and Obstructive Sleep Apnea in Type 2 Diabetic Patients: A Longitudinal Study
To follow up the progress of chronic complications in T2DM patients who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018.
Read the detailed description
Obstructive sleep apnea (OSA) is a common chronic sleep disorder and a frequent comorbidity in patients with type 2 diabetes. There has been increasing recognition that OSA is highly prevalent in persons with type 2 diabetes. This study is to explore the relationship between OSA and the progress of chronic diabetes-related complications in type 2 diabetes who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018 in the Department of Endocrinology and Diabetes, The First Affiliated Hospital of Xiamen University, Xiamen, China.
- Being tested
- regular treatment
- Keywords
- Type 2 diabetes, diabetic complications, Obstructive Sleep Apnea
- Medical subject headings
- Diabetes Complications, Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular treatmentOther
The patients with or without OSA received regular hypoglycemic drugs.
| Study group | Role | What they receive |
|---|---|---|
| T2DM with OSA | Type 2 diabetes patients with obstructive sleep apnea Receives: Other: regular treatment | |
| T2DM without OSA | Type 2 diabetes patients without obstructive sleep apnea Receives: Other: regular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the progress of diabetic complications
Diabetic complications include diabetic microvascular complications, atherosclerotic cardiovascular disease(ASCVD), and Diabetic foot disease.
Diabetic microvascular complications include diabetic nephropathy, diabetic retinopathy and diabetic neuropathy.
Diabetic macrovascular complications refer to ASCVD, which is defined as coronary heart disease (CHD; acute and silent MI, and unstable angina), ischemic stroke, or peripheral artery disease (PAD).
Measured: From January 1, 2013 to December 31, 2020
the new onset and types of tumor in T2DM patients
the new onset and types of tumor in T2DM patients
Measured: From January 1, 2013 to December 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start10 Jun 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Complications and Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646941
- Sponsor's protocol ID
- 2020-025
- Acronym
- DMOS
- Status last verified
- Aug 2023
- First submitted
- 2 Sep 2020
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analyzed in this cohort are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Complications and Obstructive Sleep Apnea in Type 2 Diabetic Patients: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT04646941
- Acronym / sponsor ID
- DMOS / 2020-025
- Keywords
- Type 2 diabetes, diabetic complications, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 30 Nov 2020 (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.
To follow up the progress of chronic complications in T2DM patients who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018.
Detailed description
Obstructive sleep apnea (OSA) is a common chronic sleep disorder and a frequent comorbidity in patients with type 2 diabetes. There has been increasing recognition that OSA is highly prevalent in persons with type 2 diabetes. This study is to explore the relationship between OSA and the progress of chronic diabetes-related complications in type 2 diabetes who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018 in the Department of Endocrinology and Diabetes, The First Affiliated Hospital of Xiamen University, Xiamen, China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM with OSA | – | Other: regular treatmentType 2 diabetes patients with obstructive sleep apnea |
| T2DM without OSA | – | Other: regular treatmentType 2 diabetes patients without obstructive sleep apnea |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 2 diabetes
Key inclusion criteria (2 listed)
- Type 2 diabetes
- Age：18-80
Key exclusion criteria (10 listed)
- Patients with non type 2 diabetes mellitus
- Preparation for pregnancy
- Lactation patients
- Patients with uncontrolled thyroid disease
- Patients with severe cardiovascular disease
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 |
|---|---|---|
| regular treatmentThe patients with or without OSA received regular hypoglycemic drugs. | Other | T2DM with OSA, T2DM without OSA |
Primary outcome
the progress of diabetic complications
Time frame: From January 1, 2013 to December 31, 2020
Diabetic complications include diabetic microvascular complications, atherosclerotic cardiovascular disease(ASCVD), and Diabetic foot disease. Diabetic microvascular complications include diabetic nephropathy, diabetic retinopathy and diabetic neuropathy. Diabetic macrovascular complications refer to ASCVD, which is defined as coronary heart disease (CHD; acute and silent MI, and unstable angina), ischemic stroke, or peripheral artery disease (PAD).
the new onset and types of tumor in T2DM patients
Time frame: From January 1, 2013 to December 31, 2020
the new onset and types of tumor in T2DM patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analyzed in this cohort are available from the corresponding author on reasonable request.
Related trials for Diabetic Complications and Obstructive Sleep Apnea
Recruiting
Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland
Diabetes Mellitus, Type 2, Obesity, Morbid
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.
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 Diabetic Complications and Obstructive Sleep Apnea, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
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 10 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 22 Aug 2023. 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 China. 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 Changqin Liu, Dr. (+86-592-2137796, liuchangqin@xmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the progress of diabetic complications (time frame: From January 1, 2013 to December 31, 2020). The study lists 2 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 22 Aug 2023.