COPD in Obese Patients

Copd Clinical Trial

Official title:

Features of Chronic Obstructive Pulmonary Disease Clinical Course in Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105075
• Other study ID #: YSShkatova
• Status: Completed
• Start date: September 9, 2018
• Est. completion date: September 20, 2019

Study information

• Verified date: September 2019
• Source: Voronezh N.N. Burdenko State Medical Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: September 20, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Copd
• Obese
• Obesity, Abdominal

Locations

Country	Name	City	State
Russian Federation	Voronezh State Medical University	Voronezh

Sponsors (1)

Lead Sponsor	Collaborator
Voronezh N.N. Burdenko State Medical Academy

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simptoms	dyspnea, sputum production and fatigue	1 year
Primary	Labotary tests	Levels of interleukins-4,6,8,10, interferon-?, tumor necrosis factor receptor 1 (TNF-R1), tumor necrosis factor receptor 2 (TNF-R2), tumor necrosis factor alpha (TNF-a) were measured in blood serum (pg / ml)	1 year
Primary	Spirometry	FEV1, % pred,FVC, % pred.,FEV1/FVC, %	1 year
Primary	Labotary tests	Levels of leptin (ng / ml) measured in blood serum	1 year
Primary	Labotary tests	Levels of adiponectin (µg / ml) measured in blood serum	1 year
Secondary	Symptroms and laboratory correlations	Statistical methods allowing to figure out associations and correlations between blood tests and symptoms	1 year