Seasonal Trends of Respiratory Morbidity in Diabetic Patients

NCT03967639 | Unknown

• 1 other identifier: WHO2788-c
• Study Type: observational
• Target: 9,838
• Locations: 1 country
• Sites: 1

Brief 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. Therefore, the study is aimed at a retrospective analysis of seasonal trends in respiratory consequences of T2DM, i.e.: i: distribution of patients with and without T2DM presenting for elective cardiac surgery during the two-year examination period; ii: characterization of respiratory co-morbidities in the patients, iii: exploring whether the respiratory mechanics at presentation and those caused by cardiac surgery exhibit different trends in T2DM and control patients.

Conditions

Diabetes Mellitus; Respiratory Complication; Perioperative/Postoperative Complications

Keywords

cardiac surgical procedures; respiratory mechanics; seasonal variation

Outcome Measures

Primary Outcomes (4)

• Seasonal variation in the incidence of diabetic patients undergoing cardiac surgery

  All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. The relative incidence of diabetic patients will be evaluated on a monthly basis in the study period.

  Retrospective data analysis (2006-2018)

• Anthropometric data of patients undergoing cardiac surgery

  All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. Anthropometric data will be collected from the patient records: height (meters) and weight (kilograms) of each patient will be collected from the hospital medical records, then these data will be combined to report BMI (kg/m\^2).

  Retrospective data analysis (2006-2018)

• Comorbidities of diabetic patients undergoing cardiac surgery

  All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. Co-morbidities (COPD, asthma, hypertension, etc.) of each patient will be collected from the hospital medical records.

  Retrospective data analysis (2006-2018)

• Smoking habits of patients undergoing cardiac surgery

  All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. Reported smoking habits (present smoker/previous smoker/never smoker; number of packs / day; duration) of each patient will be collected from the hospital medical records.

  Retrospective data analysis (2006-2018)

Study Arms (2)

Group T2DM

Patients with diabetes mellitus undergoing elective cardiac surgery

Procedure: Elective cardiac surgery

Group Ctrl

Control patients undergoing elective cardiac surgery without T2DM

Procedure: Elective cardiac surgery

Interventions

Elective cardiac surgery PROCEDURE

Elective cardiac surgery

Group Ctrl; Group T2DM

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Retrospective analysis of patient records from all patients undergoing elective cardiac surgery between January 2007 to December 2018 at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged

You may qualify if:

• all patients undergoing cardiac surgery with or without diabetes mellitus, age between 18-85 years during the time period January 2007 to December 2018

You may not qualify if:

• patients older than 85 years
• patients younger than 18 years

Sponsors & Collaborators

• Szeged University: lead
• Hungarian Basic Research Council: collaborator
• GINOP: collaborator

Study Sites (1)

Cardiology Centre Cardiac Surgical Unit and Second Department of Internal Medicine, University of Szeged

Szeged, Csongrád megye, 6725, Hungary

Location

Related Publications (1)

• Petak F, Kovacs BN, Agocs S, Virag K, Nyari T, Molnar A, Sudy R, Lengyel C, Babik B. Seasonal changes in proportion of cardiac surgeries associated with diabetes, smoking and elderly age. PLoS One. 2022 Sep 22;17(9):e0274105. doi: 10.1371/journal.pone.0274105. eCollection 2022.

  PMID: 36136994 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Postoperative Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Barna Babik, MD, PhD

  Szeged University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: May 30, 2019
• Study Start: February 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

HU (1)