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Completed

NCT Number: NCT04105075

COPD 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.

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Key information

Conditions

COPD Body Weight Chronic Disease Disease Attributes Inflammation Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Obesity, Abdominal Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Voronezh State Medical University

Voronezh, 394019, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Simptoms

    Time frame: 1 year

    dyspnea, sputum production and fatigue

  2. Labotary tests

    Time frame: 1 year

    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)

  3. Spirometry

    Time frame: 1 year

    FEV1, % pred,FVC, % pred.,FEV1/FVC, %

  4. Labotary tests

    Time frame: 1 year

    Levels of leptin (ng / ml) measured in blood serum

  5. Labotary tests

    Time frame: 1 year

    Levels of adiponectin (µg / ml) measured in blood serum

Secondary outcomes

  1. Symptroms and laboratory correlations

    Time frame: 1 year

    Statistical methods allowing to figure out associations and correlations between blood tests and symptoms

Sponsors and collaborators

Lead sponsor

Voronezh N.N. Burdenko State Medical Academy

Other

Registry information

Official study title

Features of Chronic Obstructive Pulmonary Disease Clinical Course in Obese Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2019
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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