Pulmonary Effects of Diabetes Mellitus

NCT03768973 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 310

Last updated 2019-05-16

No results posted yet for this study

Summary

Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly population results in an increased number of perioperative T2DM-related adverse effects. T2DM has a prevalence of 30-40% in a population undergoing cardiovascular surgery. Cardiac surgery, especially cardiopulmonary bypass (CPB) is also known to deteriorate respiratory mechanics. The vascular effects of T2DM are well characterized, however, its effects on the mechanical properties of the respiratory system or the exhaled carbon-dioxide concentration curve (capnogram) during and following CPB are yet to be fully discovered.

Therefore, the study is aimed at characterizing the respiratory consequences of T2DM, i.e.: i: deteriorations of airway function that might be a result of smooth muscle dysfunction; ii: deterioration of the viscoelastic properties of the lung as a result of lung volume loss or structural changes, iii: exploring whether the changes of respiratory mechanics caused by cardiac surgery exhibit a different time course in T2DM and control patients.

The study also aims at characterizing the effects of T2DM on capnogram parameters: i: whether it influences capnogram shape factors, ii: whether any differences can be detected in the dead-space parameters and iii: whether cardiac surgery has a different effect on capnogram parameters in T2DM patients compared to controls.

Conditions

Interventions

PROCEDURE

Elective cardiac surgery

Both groups will undergo elective cardiac surgery as an intervention.

Sponsors & Collaborators

  • Hungarian Basic Research Council

    collaborator OTHER
  • GINOP

    collaborator UNKNOWN
  • Szeged University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Hungary

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03768973 on ClinicalTrials.gov