DMOS: Diabetic Complications and Obstructive Sleep Apnea

Sponsor

The First Affiliated Hospital of Xiamen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04646941

Collaborator

(none)

330

Enrollment

Location

18.7

Anticipated Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Complications and Obstructive Sleep Apnea	Other: regular treatment

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

Study Type:

Observational

Anticipated Enrollment :

330 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 10, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
T2DM with OSA Type 2 diabetes patients with obstructive sleep apnea	Other: regular treatment The patients with or without OSA received regular hypoglycemic drugs.
T2DM without OSA Type 2 diabetes patients without obstructive sleep apnea	Other: regular treatment The patients with or without OSA received regular hypoglycemic drugs.

Arm

Intervention/Treatment

T2DM with OSA

Type 2 diabetes patients with obstructive sleep apnea

Other: regular treatment

The patients with or without OSA received regular hypoglycemic drugs.

T2DM without OSA

Type 2 diabetes patients without obstructive sleep apnea

Other: regular treatment

The patients with or without OSA received regular hypoglycemic drugs.

Outcome Measures

Primary Outcome Measures

the progress of diabetic complications [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 [From January 1, 2013 to December 31, 2020]
the new onset and types of tumor in T2DM patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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