Study on Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Pulmonary Infections

NCT ID: NCT03617393

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-10

Study Completion Date

2021-12-01

Brief Summary

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Focusing on patients with diabetes complicated with pulmonary infection, the purpose of this study is: 1) to identify the epidemiology, etiologic spectrum and status of diagnosis and treatment; 2) to develop a symptom score scale , clarify the risk factors and create a precise warning model; 3) to develop a rapid detection of pathogen of lower respiratory infection, to establish clinical pathways of early diagnosis and treatment of diabetes complicated with pulmonary infections (including bacterial, tuberculosis and fungal infections) and then make an application in clinic.

Detailed Description

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Investigators perform a observational study on 6000 patients with diabetes, among which 200 patients with pulmonary infection are included in a retrospective study and 100 patients go through metabolomics research. All patients receive clinical questionnaires, laboratory examinations and pulmonary function tests. Investigators study on pathogen distribution and infection ratio of patients above depending on follow-up survey. 1:1 nested case-control study is carried out involving 100 cases from pulmonary-infected group paired with 100 control cases matched for gender, age and fasting blood-glucose. The final purpose is to create a precise warning model in order to develop a rapid detection of pathogen of lower respiratory infection in diabetes patients. Now investigators wish to register this study to do a further research, in order to improve the early diagnosis of diabetes complicated with pulmonary infection and to reduce the mortality.

Conditions

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Diabetes Mellitus Pulmonary Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary Infection with DM group

Patients with diabetes and pulmonary infection.

No interventions assigned to this group

Pulmonary Infection group

Patients with pulmonary infection while the fasting blood-glucose in the normal range.

No interventions assigned to this group

DM group

Patients without pulmonary infection while the fasting blood-glucose \> 8 mmol/L.

No interventions assigned to this group

Control group: normal people

Patients without pulmonary infection while the fasting blood-glucose in the normal range.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis by pathogen examination: positive
* Diagnosis through X-ray or CT: characteristic features of pulmonary infection
* Diagnosis through guideline of diabetes or history of diagnosed diabetes
* Age 40-70 years

Exclusion Criteria

* Irregular follow-up and lost follow-up
* Withdraw from the study for any reason
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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ZHOU Min

Chief Physician of Department of Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jieming QU, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

China, Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Locations

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Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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2017YFC1309700

Identifier Type: -

Identifier Source: org_study_id

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