Arterial Hypertension, Asthma, Atherosclerosis Occlusive Disease, Diabetes Mellitus, Type 2, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Nonalcoholic Fatty Liver Disease, Obstructive Pulmonary Disease
Conditions
Keywords
chronic noncommunicable diseases, gut permeability, inflammation, gut microbiota
Brief summary
It is an observational study in patients with chronic noncommunicable diseases (i.e. cardiovascular diseases, diabetes mellitus, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease and asthma ) and control group with no signs of these conditions. The study has a prospective part planned for 2021 and a retrospective part which includes the patients enrolled between 2018-2020. The aim of the study is to investigate gut microbiota composition, its metabolites, levels of inflammatory and other markers of the disease in prospective groups (arterial hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease and control patients) as well as in retrospective groups (chronic heart failure with preserved and reduced ejection fraction, obstructive atherosclerosis of any vascular bed, arterial hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease, and control patients). Also we are planning to investigate the association between gut microbiota composition and its metabolites, levels of inflammatory and other markers of the disease in retrospective and prospective groups.
Interventions
None listed
Sponsors
Center for Strategic Planning and Management of Biomedical Health Risks of the Federal Biomedical Agency
National Medical Research Center for Therapy and Preventive Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
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): 1. No current treatment of hypertension 2. Systolic blood pressure \<180 mm Hg and diastolic blood pressure \<110 mm Hg 3. No clinical signs of other cardiovascular diseases Group of COPD and asthma (inclusion criteria) 1. Medical records, confirming COPD or asthma 2. 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. 3. Absence of acute exacerbations of COPD, asthma or any concomitant diseases 4 weeks before the enrollment 4. No use of genetically engineered biological drugs 5. 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) 1. Confirmed type 2 diabetes mellitus 2. Stable glucose lowering treatment for ≥ 1 month 3. No systemic corticosteroid treatment 4 weeks before the enrollment Group of NAFLD (inclusion criteria) 1. Ultrasound criteria of non-alcoholic fatty liver disease or 2. Confirmed non-alcoholic fatty liver disease using FibroMax test Control group inclusion criteria 1. Men and women aged ≥ 18 and \<80 years 2. Signed informed consent form Control group for arterial hypertension (inclusion criteria): 1\. No history of cardiovascular diseases, COPD or asthma Control group for COPD and asthma (inclusion criteria): 1\. No history of diabetes mellitus, NAFLD, COPD and asthma
Exclusion criteria
for all groups 1. Age \< 18 years and ≥80 years 2. Denial of further participation 3. Obesity with BMI≥40 kg/m2 4. History of organ transplantion 5. Psychiatric disorder, limiting participation in the study 6. Acute infections 7. Exacerbation of chronic infection 2 weeks before the enrollment 8. Cancer with no radical treatment 9. Pregnancy and lactation 10. Alcohol and drug addition 11. Chronic kidney disease with GFR \<30 ml/min/1.73m2 12. Systemic autoimmune diseases 13. Inflammatory bowel disease 14. Antimicrobial and probiotic treatment 3 months before the enrollment Additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant (p<0,05) correlation (r>0,5) between abundance of Faecalibacterium genus and concentration of lipopolysaccharide | on enrollment |
Countries
Russia
Outcome results
None listed