Diabetic Complications and Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diabetic Complications and Obstructive Sleep Apnea in Type 2 Diabetic Patients: A Longitudinal Study

Conditions
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Diabetic Complications and Obstructive Sleep Apnea

Intervention / Treatment
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* Other: regular treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Age：18-80 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2DM with OSA<br>Type 2 diabetes patients with obstructive sleep apnea | Other: regular treatment<br>* The patients with or without OSA received regular hypoglycemic drugs.<br>|
| T2DM without OSA<br>Type 2 diabetes patients without obstructive sleep apnea | Other: regular treatment<br>* The patients with or without OSA received regular hypoglycemic drugs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | From January 1, 2013 to December 31, 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, diabetic complications, Obstructive Sleep Apnea