Diabetic Complications and Obstructive Sleep Apnea

NCT04646941 | Unknown

• 1 other identifier: 2020-025
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Complications and Obstructive Sleep Apnea

Keywords

Type 2 diabetes; diabetic complications; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

T2DM with OSA

Type 2 diabetes patients with obstructive sleep apnea

Other: regular treatment

T2DM without OSA

Type 2 diabetes patients without obstructive sleep apnea

Other: regular treatment

Interventions

regular treatment OTHER

The patients with or without OSA received regular hypoglycemic drugs.

T2DM with OSA; T2DM without OSA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Type 2 diabetes

You may qualify if:

• Type 2 diabetes
• Age：18-80

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The first affiliated hospital of Xiamen university

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Diabetes Complications; Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Changqin Liu, Dr.

CONTACT

+86-592-2137796; liuchangqin@xmu.edu.cn

Xin Zheng

CONTACT

+86-592-2137796; 88126386@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: November 30, 2020
• Study Start: June 10, 2020
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

CN (1)