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Status:

COMPLETED

Gut Microbiota in Chronic Noncommunicable Diseases

Lead Sponsor:

National Medical Research Center for Therapy and Preventive Medicine

Collaborating Sponsors:

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

Conditions:

Arterial Hypertension

Atherosclerosis Occlusive Disease

Eligibility:

All Genders

18-79 years

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 diseas...

Eligibility Criteria

Inclusion

  • 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):
  • 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
  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 12 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2021

    Estimated Enrollment :

    1084 Patients enrolled

    Trial Details

    Trial ID

    NCT04820556

    Start Date

    April 12 2021

    End Date

    December 1 2021

    Last Update

    April 19 2022

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

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

    Moscow, Russia, 101990

    2

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

    Moscow, Russia, 119121