Diabetic Complications and Obstructive Sleep Apnea (DMOS)

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.

Study Overview

Status

Recruiting

Intervention / 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 Type

Observational

Enrollment (Estimated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with Type 2 diabetes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T2DM with OSA
Type 2 diabetes patients with obstructive sleep apnea
The patients with or without OSA received regular hypoglycemic drugs.
T2DM without OSA
Type 2 diabetes patients without obstructive sleep apnea
The patients with or without OSA received regular hypoglycemic drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

From January 1, 2013 to December 31, 2020
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
From January 1, 2013 to December 31, 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (Actual)

November 30, 2020

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 19, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets used and/or analyzed in this cohort are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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