COPD in Obese Patients

Completed

• Conditions: Copd; Obesity, Abdominal; Obese

• Registration Number: NCT04105075
• Lead Sponsor: Voronezh N.N. Burdenko State Medical Academy

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-09-09
• Status Verified: 2019-09
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-20
• Study First Submitted: 2019-09-22
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Labotary tests	1 year	Levels of adiponectin (µg / ml) measured in blood serum
Spirometry	1 year	FEV1, % pred,FVC, % pred.,FEV1/FVC, %
Simptoms	1 year	dyspnea, sputum production and fatigue

Secondary Outcome Measures

Name	Time	Method
Symptroms and laboratory correlations	1 year	Statistical methods allowing to figure out associations and correlations between blood tests and symptoms

Trial Locations

Locations (1)

Voronezh State Medical University; 🇷🇺 Voronezh, Russian Federation