COPD in Obese Patients

Features of Chronic Obstructive Pulmonary Disease Clinical Course in Obese Patients

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.

Study Overview

• Status: Completed
• Conditions: Copd; Obese; Obesity, Abdominal

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• Russian Federation
  • Voronezh, Russian Federation, 394019
    • Voronezh State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study included 176 patients with COPD. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2019) classification, all patients belonged to the group D, GOLD 2-4 (GOLD 1 = forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, GOLD 2 = 50 ≤ FEV1 ≤ 80% predicted, GOLD 3 = 30 ≤ FEV1 ≤ 50% predicted, GOLD 4 = FEV1 < 30% predicted). Patients were divided in two groups depending on the body mass index (BMI): 18.5-24.99 kg / m2 - normal weight, 30 kg / m2 and more - obesity. The first group (group 1) included 88 patients with COPD and normal weight: 71 (80.68%) men and 17 (19.32%) women aged from 43 to 72 years (mean age 62.40 ± 8.83 years). The second group (group 2) - 88 patients with COPD and obesity: 64 (72.73%) men and 24 (27.27%) women aged from 50 to 72 years (mean age 62.94 ± 5.96 years).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with COPD and obesity; Patients consented to have a blood sample taken
Normal body weight patients with COPD; Patients consented to have a blood sample taken

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simptoms	dyspnea, sputum production and fatigue	1 year
Labotary tests	Levels of interleukins-4,6,8,10, interferon-γ, 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 (pg / ml)	1 year
Spirometry	FEV1, % pred,FVC, % pred.,FEV1/FVC, %	1 year
Labotary tests	Levels of leptin (ng / ml) measured in blood serum	1 year
Labotary tests	Levels of adiponectin (µg / ml) measured in blood serum	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptroms and laboratory correlations	Statistical methods allowing to figure out associations and correlations between blood tests and symptoms	1 year

Collaborators and Investigators

• Sponsor: Voronezh N.N. Burdenko State Medical Academy
• Investigators: Study Director: Andrey Budnevsky, Voronezh State Medical Univercity

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2018
• Primary Completion (Actual): September 10, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: September 22, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: spirometry; inflammation; copd
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Obesity, Abdominal
• Other Study ID Numbers: YSShkatova

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No