Status:
COMPLETED
Evaluation of the Effect of IHHT on Vascular Stiffness and Elasticity of the Liver Tissue in Patients With MS.
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Vascular Stiffness
Liver Fibroses
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04791397
Start Date
April 10 2019
End Date
December 3 2020
Last Update
March 10 2021
Active Locations (1)
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1
University Clinical Hospital №1 Sechenov University
Moscow, Russia, 119435