Clinical trial NCT04791397: 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
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the arterial stiffness.
timeFrame: Assessment will be measured next day after 15th procedure of the IHHT procedure.
measure: Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the liver fibrosis.
timeFrame: Assessment will be measured next day after 15th procedure of the IHHT procedure.
Secondary outcomes:
measure: Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the lipid profile ( total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides in mmol/l).
timeFrame: Assessment will be measured next day after 15th procedure of the IHHT procedure.
measure: Assess the effect of interval hypoxy-hyperoxic training (IHHT) on the trimethylamine n-oxide in mg/dl.
timeFrame: Assessment will be measured next day after 15th procedure of the IHHT procedure.
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: University Clinical Hospital №1 Sechenov University
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Philippe Yu Kopylov, professor
role: STUDY_DIRECTOR
References:
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.