Clinical trial NCT04105075: COPD in Obese Patients
Official title: Features of Chronic Obstructive Pulmonary Disease Clinical Course in Obese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copd
Obese
Obesity, Abdominal
Keywords: spirometry
inflammation
copd
Lead sponsor: Voronezh N.N. Burdenko State Medical Academy
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 176
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Simptoms
timeFrame: 1 year
measure: Labotary tests
timeFrame: 1 year
measure: Spirometry
timeFrame: 1 year
measure: Labotary tests
timeFrame: 1 year
measure: Labotary tests
timeFrame: 1 year
Secondary outcomes:
measure: Symptroms and laboratory correlations
timeFrame: 1 year
Other outcomes:
Locations:
city: Voronezh
country: Russian Federation
facility: Voronezh State Medical University
Study officials:
affiliation: Voronezh State Medical Univercity
name: Andrey Budnevsky
role: STUDY_DIRECTOR
References: