Gut Microbiota in Chronic Noncommunicable Diseases

NCT ID: NCT04820556

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1084 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2021-12-01

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.

Conditions

Arterial Hypertension; Atherosclerosis Occlusive Disease; Heart Failure With Preserved Ejection Fraction; Heart Failure With Reduced Ejection Fraction; Diabetes Mellitus, Type 2; Obstructive Pulmonary Disease; Asthma; Nonalcoholic Fatty Liver Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Arterial hypertension

No interventions assigned to this group

Atherosclerosis occlusive disease

No interventions assigned to this group

Heart failure with preserved ejection fraction

No interventions assigned to this group

Heart failure with reduced ejection fraction

No interventions assigned to this group

Diabetes mellitus, type 2

No interventions assigned to this group

Chronic obstructive pulmonary disease and asthma

No interventions assigned to this group

Nonalcoholic fatty liver disease

No interventions assigned to this group

Control group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

All mentioned groups:

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

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

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

1. Confirmed type 2 diabetes mellitus

2. Stable glucose lowering treatment for ≥ 1 month

3. No systemic corticosteroid treatment 4 weeks before the enrollment

1. Ultrasound criteria of non-alcoholic fatty liver disease or

2. Confirmed non-alcoholic fatty liver disease using FibroMax test

1. Men and women aged ≥ 18 and <80 years

2. Signed informed consent form

1. No history of cardiovascular diseases, COPD or asthma

1. No history of diabetes mellitus, NAFLD, COPD and asthma

1. Men and women aged ≥ 18 and <80 years

2. Signs and symptoms of heart failure

3. Left ventricular diastolic dysfunction

4. Left ventricular ejection fraction ≥50%

5. NT-pro BNP >125 pg/ml

6. Signed study informed consent form

1. Men and women aged ≥ 35 and <80 years

2. Signs and symptoms of heart failure

3. Left ventricular ejection fraction <50%

4. Signed study informed consent form

1. Men and women aged ≥ 35 and <80 years

2. Symptoms and signs of obstructive atherosclerosis of any vascular bed:

1. Ischemic heart disease or

2. Revascularization of coronary, renal, brachiocephalic or lower extremity arteries or

3. carotid endarterectomy or

4. chronic lower extremity ischemia or

5. history of myocardial infarction, stroke, transient ischemic attack or

6. renovascular AH

7. atherosclerotic aorta aneurysm

3. Signed study informed consent form

1. Men and women aged ≥ 18 and <80 years.

2. No signs or symptoms of chronic heart failure

3. No signs of left ventricular diastolic dysfunction

4. No history, signs or symptoms of obstructive atherosclerosis of any vascular bed

5. Signed study informed consent form

Exclusion Criteria

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

1. Ischemic heart disease (angina pectoris, myocardial infarction), cerebrovascular disease (stroke, transient ischemic attack), occlusive peripheral arterial disease, revascularization of any vascular bed.

2. Cardiomyopathies

3. Symptomatic arterial hypertension

4. Diabetes mellitus

5. Signs of previous myocardial infarction on ECG

6. Arrhythmias (parohysmal arrhythmias, atrial fibrillation, sinoatrial block, atrioventricular block grade II-III)

7. Signs of current myocardial ischemia on ECG

8. Decompensated heart failure

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

2. Type 1 diabetes mellitus and other specific types of diabetes

3. 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

4. The history of moderate, severe and very severe COPD

5. The history of moderate or severe asthma

6. Vegetarians or vegans

1. Chronic liver diseases except NAFLD

2. The history of moderate, severe and very severe COPD

3. The history of moderate or severe asthma

4. Vegetarians or vegans

5. Diabetes mellitus

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

1. Age <18 and ≥80 years.

2. Refuse to sign study informed consent form

3. Body mass index ≥35 kg/m2

4. Chronic kidney disease with GFR <30 ml/min/1,73 m2

5. Current smoking

6. Moderate or severe COPD

7. Moderate or severe asthma

8. Acute infections or exacerbation of chronic infections 2 weeks prior to study enrollment

9. History of allergic reactions to gadolinium contrast

10. Hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy: primary, amyloidosis, glycogen storage diseases, hemochromatosis, sarcoidosis, drug induced cardiomyopathy, radiation heart disease, constrictive pericarditis).

11. Connective tissue disease

12. Cancer with no radical treatment

13. Pregnancy or lactation

14. Inflammatory bowel disease

15. Use of antimicrobial agents, probiotics or systemic corticosteroids 3 months before the enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Strategic Planning and Management of Biomedical Health Risks of the Federal Biomedical Agency

UNKNOWN

Sponsor Role: collaborator

National Medical Research Center for Therapy and Preventive Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anastasia Kaburova

junior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthcare of the Russian Federation

Moscow, , Russia

Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency

Moscow, , Russia

Countries

Russia

Other Identifiers

3162021

Identifier Type: -

Identifier Source: org_study_id