COPD in Obese Patients

NCT ID: NCT04105075

Last Updated: 2019-10-03

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

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-09

Study Completion Date

2019-09-20

Brief Summary

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The study included 176 patients with COPD. The first group included 88 normal weight patients with COPD: 71 men and 17 women, mean age 62.40 ± 8.83 years. The second group included 88 patients with COPD and obesity: 64 men and 24 women, mean age 62.94 ± 5.96 years. We assessed the frequency of COPD exacerbations in last 12 months, the severity of symptoms such as dyspnea, sputum production, fatigue. Spirometry, six-minute walk test and analysis of body tissue type composition were performed. BODE index was calculated. Levels of leptin, adiponectin, interleukins-4,6,8,10, interferon-γ, c-reactive protein (CRP), tumor necrosis factor receptor 1 (TNF-R1), tumor necrosis factor receptor 2 (TNF-R2), tumor necrosis factor alpha (TNF-α) were measured in blood serum.

Detailed Description

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Conditions

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Copd Obese Obesity, Abdominal

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with COPD and obesity

Patients consented to have a blood sample taken

No interventions assigned to this group

Normal body weight patients with COPD

Patients consented to have a blood sample taken

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* COPD diagnosis, informed consent for voluntary participation in the study

Exclusion Criteria

* patient participation in any interventional study,
* COPD exacerbation,
* concomitant lung diseases, such as confirmed or suspected malignant lung disease or other respiratory disease, such as interstitial pulmonary fibrosis, tuberculosis, sarcoidosis, bronchial asthma, bronchiectasis,
* concomitant diseases of other organs and systems, such as acute cardiovascular diseases, chronic kidney diseases and liver failure.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Voronezh N.N. Burdenko State Medical Academy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrey Budnevsky

Role: STUDY_DIRECTOR

Voronezh State Medical Univercity

Locations

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Voronezh State Medical University

Voronezh, , Russia

Site Status

Countries

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Russia

Other Identifiers

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YSShkatova

Identifier Type: -

Identifier Source: org_study_id

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