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

NCT04791397 | Completed

• 1 other identifier: A0519
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 Outcomes (2)

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

  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.

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

Study Arms (2)

Group trial

EXPERIMENTAL

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

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

Group control

EXPERIMENTAL

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

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

Interventions

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

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.

Group trial

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

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.

Group control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

University Clinical Hospital №1 Sechenov University

Moscow, 119435, Russia

Location

Related Publications (1)

• 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.

  PMID: 34513946 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver

Study Officials

• Philippe Yu Kopylov, professor

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: March 10, 2021
• Study Start: April 10, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 3, 2020
• Last Updated: March 10, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)