COPD in Obese Patients

NCT04105075 | Completed

• 1 other identifier: YSShkatova
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; Obese; Obesity, Abdominal

Keywords

spirometry; inflammation; copd

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Symptroms and laboratory correlations

  1 year

Study Arms (2)

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

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Voronezh N.N. Burdenko State Medical Academy: lead

Study Sites (1)

Voronezh State Medical University

Voronezh, 394019, Russia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Obesity; Obesity, Abdominal; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Andrey Budnevsky

  Voronezh State Medical Univercity

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 26, 2019
• Study Start: September 9, 2018
• Primary Completion: September 10, 2019
• Study Completion: September 20, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)