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Evaluation of the Effect of IHHT on Vascular Stiffness and Elasticity of the Liver Tissue in Patients With MS.

Primary Purpose

Vascular Stiffness, Liver Fibroses, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.

Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.

About this trial

This is an interventional treatment trial for Vascular Stiffness focused on measuring Metabolic syndrome, Vascular Aging, Non-alcoholic Fatty Liver Disease, Non-drug methods, Interval Hypoxic-hyperoxic training, Trimethylamine N-oxyde (TMAO), Toll-like Receptors (TLR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient's written informed consent.
The presence of metabolic syndrome: as having three or more of the following traits, including traits you're taking medication to control:
Large waist - A waistline that measures at least 35 inches (89 centimeters) for women and 40 inches (102 centimeters) for men;
High triglyceride level - 150 milligrams per deciliter (mg/dL), or 1.7 millimoles per liter (mmol/L), or higher of this type of fat found in blood;
Reduced "good" or HDL cholesterol - Less than 40 mg/dL (1.04 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women of high-density lipoprotein (HDL) cholesterol;
Increased blood pressure - 130/85 millimeters of mercury (mm Hg) or higher;
Elevated fasting blood sugar - 100 mg/dL (5.6 mmol/L) or higher.
Must be able to come to the hospital 5 days per week, for 3 weeks.

Exclusion Criteria:

Refusal from further participation in the study.
Individual intolerance to hypoxia.
Cirrhosis of the liver with liver failure class C according to the classification of Child-Pugh.
Alcohol use 140 g / week or more for men, and 70 g / week or more for women.
Patients with positive serological reactions to hepatitis B and C.
Chronic kidney disease (GFR less than 30 ml / min / 1.73 m 2).
Pregnancy, lactation.

Sites / Locations

University Clinical Hospital №1 Sechenov University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group trial

Group control

Arm Description

Included 30 patients, with metabolic syndrome, aged 24-71 year old.

Outcomes

Primary Outcome Measures

Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the arterial stiffness.

Assessment of arterial stiffness will be measured by pulse wave velocity using VASERA VS-1500 Fukuda Denshi on next day after course of 15 procedures of IHHT.

Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the liver fibrosis.

Assessment of the liver fibrosis and elasticity of liver tissue will be measurement by elastography on FibroScan (Echosense, XL-sensor) by measured liver tissue stiffness (in KPa).

Secondary Outcome Measures

Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the lipid profile ( total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides in mmol/l).

Taken in blood.

Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the trimethylamine n-oxide in mg/dl.

Taken in blood.

Full Information

NCT ID

NCT04791397

First Posted

May 13, 2020

Last Updated

March 8, 2021

Sponsor

I.M. Sechenov First Moscow State Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04791397

Brief Title

Evaluation of the Effect of IHHT on Vascular Stiffness and Elasticity of the Liver Tissue in Patients With MS.

Official Title

Double-Blind, Placebo-Controlled, Randomized Parallel Design Trial of Evaluation of the Effect of Interval Hypoxic-hyperoxic Training (IHHT) on Vascular Stiffness and Elasticity of the Liver Tissue in Patients With Metabolic Syndrome.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

April 10, 2019 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

December 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to assess the effect of interval hypoxy-hyperoxic training (IHHT) on the arterial stiffness and elasticity of the liver tissue in patients with metabolic syndrome and on other components of the metabolic syndrome, and the possibility of their reversible recovery after training.

Detailed Description

The study will included 60 patients with metabolic syndrome (alimentary obesity (large waist, that measures at least 89 centimeters for women, and 102 centimeters for men), high blood pressure (130/85 mm Hg or higher), dislipidemia (triglyceride level 150 mg/dL (1.7 mmol/L) or higher of this type of fat found in blood; reduced high-density lipoprotein (HDL) cholesterol less than 40 mg/dL (1.04 mmol/L) in men, or less than 50 mg/dL (1.3 mmol/L) in women of HDL cholesterol), elevated fasting blood sugar (100 mg/dL (5,6 mmol/L) or higher). All patients were random separated into two groups: trial (30 pers., who will undergo 15 procedures of the IHHT, 5 days a week for 3 weeks), and control (30 pers., who will undergo 15 placebo procedures simulating IHHT, 5 days a week for 3 weeks). Before and after procedures of IHHT all patients will undergo laboratory and instrumental examinations, wich include arterial stiffness measurement, making by Fukuda Denshi VS-100 VaSera, measurement of liver tissue elasticity and fibrosis, making by elastography on FibroScan (Echosense, XL-sensor), and laboratory analysis (lipid profile, fasting blood sugar, trimethylamin N-oxyde (TMAO), Toll-like receptors 4,7,9). After 6 month of IHHT all patients will undergo the same laboratory and instrumental examinations to assess the duration of the effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vascular Stiffness, Liver Fibroses, Metabolic Syndrome, Trimethylamine N-oxyde, Toll-like Receptors

Keywords

Metabolic syndrome, Vascular Aging, Non-alcoholic Fatty Liver Disease, Non-drug methods, Interval Hypoxic-hyperoxic training, Trimethylamine N-oxyde (TMAO), Toll-like Receptors (TLR)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group trial

Arm Type

Experimental

Arm Description

Included 30 patients, with metabolic syndrome, aged 24-71 year old.

Arm Title

Group control

Arm Type

Experimental

Arm Description

Included 30 patients, with metabolic syndrome, aged 24-71 year old.

Intervention Type

Procedure

Intervention Name(s)

Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.

Intervention Description

Every patient from control group undergo 15 procedures of IHHT, 5 procedures per week for 3 weeks, 1 procedure lasts 40 minutes. IHHT is a protocol which employs passive (the patient is at rest), short (several minutes) mild normobaric hypoxic exposures alternated with similar duration intervals of breathing hyperoxia, and repeated for 40 minutes. During the initial pretreatment test, the patient inhales air with low oxygen content at atmospheric pressure in a continuous mode through a mask. In the interval therapeutic mode that follows, periods of hypoxia (10-14% O2) are interrupted by periods of reoxygenation by hyperoxia (up to 35% O2). Automatic switching of gas flows (SRT technology). Built-in intelligent software automatically identifies and suggests key treatment parameters for the individual treatment program, by adjusting the starting parameters based upon the results of the pretreatment hypoxic test.

Intervention Type

Procedure

Intervention Name(s)

Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.

Intervention Description

Every patient from group control undergo simulating procedures of interval hypoxic-hyperoxic training, 15 procedures, 5 procedures per week for 3 weeks. 1 procedure lasts 40 minutes, in normoxia. Before the start of the course, each patient undergoes a test procedure for 10 minute (in normoxia) for simulate procedures IHHT.

Primary Outcome Measure Information:

Title

Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the arterial stiffness.

Description

Assessment of arterial stiffness will be measured by pulse wave velocity using VASERA VS-1500 Fukuda Denshi on next day after course of 15 procedures of IHHT.

Time Frame

Assessment will be measured next day after 15th procedure of the IHHT procedure.

Title

Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the liver fibrosis.

Description

Assessment of the liver fibrosis and elasticity of liver tissue will be measurement by elastography on FibroScan (Echosense, XL-sensor) by measured liver tissue stiffness (in KPa).

Time Frame

Assessment will be measured next day after 15th procedure of the IHHT procedure.

Secondary Outcome Measure Information:

Title

Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the lipid profile ( total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides in mmol/l).

Description

Taken in blood.

Time Frame

Assessment will be measured next day after 15th procedure of the IHHT procedure.

Title

Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the trimethylamine n-oxide in mg/dl.

Description

Taken in blood.

Time Frame

Assessment will be measured next day after 15th procedure of the IHHT procedure.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient's written informed consent. The presence of metabolic syndrome: as having three or more of the following traits, including traits you're taking medication to control: Large waist - A waistline that measures at least 35 inches (89 centimeters) for women and 40 inches (102 centimeters) for men; High triglyceride level - 150 milligrams per deciliter (mg/dL), or 1.7 millimoles per liter (mmol/L), or higher of this type of fat found in blood; Reduced "good" or HDL cholesterol - Less than 40 mg/dL (1.04 mmol/L) in men or less than 50 mg/dL (1.3 mmol/L) in women of high-density lipoprotein (HDL) cholesterol; Increased blood pressure - 130/85 millimeters of mercury (mm Hg) or higher; Elevated fasting blood sugar - 100 mg/dL (5.6 mmol/L) or higher. Must be able to come to the hospital 5 days per week, for 3 weeks. Exclusion Criteria: Refusal from further participation in the study. Individual intolerance to hypoxia. Cirrhosis of the liver with liver failure class C according to the classification of Child-Pugh. Alcohol use 140 g / week or more for men, and 70 g / week or more for women. Patients with positive serological reactions to hepatitis B and C. Chronic kidney disease (GFR less than 30 ml / min / 1.73 m 2). Pregnancy, lactation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Yu Kopylov, professor

Organizational Affiliation

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Official's Role

Study Director

Facility Information:

Facility Name

University Clinical Hospital №1 Sechenov University

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Prohibition of local ethics committee

Citations:

PubMed Identifier

34513946

Citation

Afina AB, Oleg SG, Alexander AB, Ines D, Alexander Yu S, Nikita VV, Denis ST, Daria GG, Zhang Y, Chavdar SP, Dmitriy VG, Elena AS, Irina VK, Philippe Yu K. The Effects of Intermittent Hypoxic-Hyperoxic Exposures on Lipid Profile and Inflammation in Patients With Metabolic Syndrome. Front Cardiovasc Med. 2021 Aug 27;8:700826. doi: 10.3389/fcvm.2021.700826. eCollection 2021.

Results Reference

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Evaluation of the Effect of IHHT on Vascular Stiffness and Elasticity of the Liver Tissue in Patients With MS.

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