Vascular StiffnessNCT04791397
Evaluation of the Effect of IHHT on Vascular Stiffness and Elasticity of the Liver Tissue in Patients With MS.
A study testing Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy. and Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy. in people with Vascular Stiffness and Liver Fibroses, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Stiffness, Liver Fibroses, Metabolic Syndrome
- What is being tested?
- Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy. and Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteRussia
- Study dates
- 10 Apr 2019to 3 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
University Clinical Hospital №1 Sechenov University
Moscow, 119435
About this study
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.
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.
Read the 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.
- Conditions
- Vascular Stiffness, Liver Fibroses, Metabolic Syndrome, Trimethylamine N-oxyde, Toll-like Receptors
- Being tested
- Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy., Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.
- 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)
- Medical subject headings
- Liver Cirrhosis, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.Procedure or surgery
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.
Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group trial | Experimental | Included 30 patients, with metabolic syndrome, aged 24-71 year old. Receives: 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. Receives: Procedure: Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Taken in blood.
Measured: 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.
Taken in blood.
Measured: Assessment will be measured next day after 15th procedure of the IHHT procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start10 Apr 2019
- Primary completion30 Nov 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Yu Kopylov, professor, Study director, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791397
- Sponsor's protocol ID
- A0519
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prohibition of local ethics committee
Publications
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.
PubMed 34513946
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04791397
- Acronym / sponsor ID
- A0519
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group trial | Experimental | Procedure: Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.Included 30 patients, with metabolic syndrome, aged 24-71 year old. |
| Group control | Experimental | Procedure: Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.Included 30 patients, with metabolic syndrome, aged 24-71 year old. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group trial |
| 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. | Procedure or surgery | Group control |
Primary outcome
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.
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).
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 34513946Afina 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.
- Individual participant dataSharing planned: No. Prohibition of local ethics committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Yu Kopylov, professor study director
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy. and Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy. in people with Vascular Stiffness and Liver Fibroses, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.