Gut Microbiota in Chronic Noncommunicable Diseases

Criteria for groups with arterial hypertension, chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes mellitus and nonalcoholic fatty liver disease (NAFLD) (both prospective and retrospective)

Inclusion criteria

All mentioned groups:

• Men and women aged ≥ 18 and <80
• Signed informed consent form

Group of arterial hypertention (inclusion criteria):

• No current treatment of hypertension
• Systolic blood pressure <180 mm Hg and diastolic blood pressure <110 mm Hg
• No clinical signs of other cardiovascular diseases

Group of COPD and asthma (inclusion criteria)

• Medical records, confirming COPD or asthma
• Regular stable treatment of COPD, asthma or any chronic disease for ≥ 4 weeks before the enrollment. If inhaled corticosteroids are being used, regular treatment is required for ≥12 weeks.
• Absence of acute exacerbations of COPD, asthma or any concomitant diseases 4 weeks before the enrollment
• No use of genetically engineered biological drugs
• For patients with COPD after inhalation of salbutamol (400 mcg) the ratio FEV1/FVC is less than 0,70

Group of type 2 diabetes mellitus (inclusion criteria)

• Confirmed type 2 diabetes mellitus
• Stable glucose lowering treatment for ≥ 1 month
• No systemic corticosteroid treatment 4 weeks before the enrollment

Group of NAFLD (inclusion criteria)

• Ultrasound criteria of non-alcoholic fatty liver disease or
• Confirmed non-alcoholic fatty liver disease using FibroMax test

Control group inclusion criteria

• Men and women aged ≥ 18 and <80 years
• Signed informed consent form

Control group for arterial hypertension (inclusion criteria):

• No history of cardiovascular diseases, COPD or asthma

Control group for COPD and asthma (inclusion criteria):

• No history of diabetes mellitus, NAFLD, COPD and asthma

Exclusion criteria

for all groups

• Age < 18 years and ≥80 years
• Denial of further participation
• Obesity with BMI≥40 kg/m2
• History of organ transplantion
• Psychiatric disorder, limiting participation in the study
• Acute infections
• Exacerbation of chronic infection 2 weeks before the enrollment
• Cancer with no radical treatment
• Pregnancy and lactation
• Alcohol and drug addition
• Chronic kidney disease with GFR <30 ml/min/1.73m2
• Systemic autoimmune diseases
• Inflammatory bowel disease
• Antimicrobial and probiotic treatment 3 months before the enrollment

Additional exclusion criteria adjusted for each group

Group of arterial hypertension (exclusion criteria):

• Ischemic heart disease (angina pectoris, myocardial infarction), cerebrovascular disease (stroke, transient ischemic attack), occlusive peripheral arterial disease, revascularization of any vascular bed.
• Cardiomyopathies
• Symptomatic arterial hypertension
• Diabetes mellitus
• Signs of previous myocardial infarction on ECG
• Arrhythmias (parohysmal arrhythmias, atrial fibrillation, sinoatrial block, atrioventricular block grade II-III)
• Signs of current myocardial ischemia on ECG
• Decompensated heart failure

Group of COPD and asthma (exclusion criteria):

• Exacerbation of COPD or asthma 3 months before the enrollment which required antibiotic treatment or systemic corticosteroids.

Group of type 2 diabetes mellitus (exclusion criteria):

• Type 1 diabetes mellitus and other specific types of diabetes
• Severe microangiopathy: proliferative and terminal stage of diabetic retinopathy, chronic kidney disease (GFR < 30 ml/min/1,73 m2) for patients with type 2 diabetes
• The history of moderate, severe and very severe COPD
• The history of moderate or severe asthma
• Vegetarians or vegans

Group of non-alcoholic fatty liver disease (exclusion criteria):

• Chronic liver diseases except NAFLD
• The history of moderate, severe and very severe COPD
• The history of moderate or severe asthma
• Vegetarians or vegans
• Diabetes mellitus

Criteria for groups of heart failure and obstructive atherosclerosis (retrospective)

Inclusion criteria

for HF-pEF group:

• Men and women aged ≥ 18 and <80 years
• Signs and symptoms of heart failure
• Left ventricular diastolic dysfunction
• Left ventricular ejection fraction ≥50%
• NT-pro BNP >125 pg/ml
• Signed study informed consent form

Inclusion criteria

for HF-rEF group:

• Men and women aged ≥ 35 and <80 years
• Signs and symptoms of heart failure
• Left ventricular ejection fraction <50%
• Signed study informed consent form

Inclusion criteria

for obstructive atherosclerosis group:

• Men and women aged ≥ 35 and <80 years
• Symptoms and signs of obstructive atherosclerosis of any vascular bed:

• Ischemic heart disease or
• Revascularization of coronary, renal, brachiocephalic or lower extremity arteries or
• carotid endarterectomy or
• chronic lower extremity ischemia or
• history of myocardial infarction, stroke, transient ischemic attack or
• renovascular AH
• atherosclerotic aorta aneurysm
• Signed study informed consent form

Inclusion criteria

for control group for HF-pEF, HF-rEF and obstructive atherosclerosis

• Men and women aged ≥ 18 and <80 years.
• No signs or symptoms of chronic heart failure
• No signs of left ventricular diastolic dysfunction
• No history, signs or symptoms of obstructive atherosclerosis of any vascular bed
• Signed study informed consent form

Exclusion criteria

for groups with HF-pEF, HF-rEF and obstructive atherosclerosis:

• Age <18 and ≥80 years.
• Refuse to sign study informed consent form
• Body mass index ≥35 kg/m2
• Chronic kidney disease with GFR <30 ml/min/1,73 m2
• Current smoking
• Moderate or severe COPD
• Moderate or severe asthma
• Acute infections or exacerbation of chronic infections 2 weeks prior to study enrollment
• History of allergic reactions to gadolinium contrast
• Hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy: primary, amyloidosis, glycogen storage diseases, hemochromatosis, sarcoidosis, drug induced cardiomyopathy, radiation heart disease, constrictive pericarditis).
• Connective tissue disease
• Cancer with no radical treatment
• Pregnancy or lactation
• Inflammatory bowel disease
• Use of antimicrobial agents, probiotics or systemic corticosteroids 3 months before the enrollment