Diabetic Complications and Obstructive Sleep Apnea

Diabetic Complications and Obstructive Sleep Apnea Clinical Trial

— DMOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04646941
• Other study ID #: 2020-025
• Status: Recruiting
• Start date: June 10, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: August 2023
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Changqin Liu, Dr.
• Phone: +86-592-2137796
• Email: liuchangqin[@]xmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Diabetes Complications
• Diabetic Complications and Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• regular treatment
The patients with or without OSA received regular hypoglycemic drugs.

Locations

Country	Name	City	State
China	The first affiliated hospital of Xiamen university	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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