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

March 8, 2021 updated by: I.M. Sechenov First Moscow State Medical University

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119435
        • University Clinical Hospital №1 Sechenov University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group trial
Included 30 patients, with metabolic syndrome, aged 24-71 year old.
Procedure: Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.
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.
Experimental: Group control
Included 30 patients, with metabolic syndrome, aged 24-71 year old.
Procedure: Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the arterial stiffness.
Time Frame: Assessment will be measured next day after 15th procedure of the IHHT procedure.
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.
Assessment will be measured next day after 15th procedure of the IHHT procedure.
Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the liver fibrosis.
Time Frame: Assessment will be measured next day after 15th procedure of the IHHT procedure.
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).
Assessment will be measured next day after 15th procedure of the IHHT procedure.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the lipid profile ( total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides in mmol/l).
Time Frame: Assessment will be measured next day after 15th procedure of the IHHT procedure.
Taken in blood.
Assessment will be measured next day after 15th procedure of the IHHT procedure.
Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the trimethylamine n-oxide in mg/dl.
Time Frame: Assessment will be measured next day after 15th procedure of the IHHT procedure.
Taken in blood.
Assessment will be measured next day after 15th procedure of the IHHT procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
I.M. Sechenov First Moscow State Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A0519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Prohibition of local ethics committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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