Study of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old
NCT04897113 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2021-05-21
Summary
Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most accessible for testing. We know that, with age, there is increase in levels of LDL, triglycerides, homocysteine and other biomarkers relating the body state.
Methods of extracorporeal hemocorrection showed good results in this area. For instance, the use of plasmapheresis is very effective during prophylaxis, treatment and rehabilitation after various diseases/injuries. The main effects of plasmapheresis are related to removal of endo- and exotoxins, including products of lipid peroxidation, and to draining effect as a result of a heavy flow of interstitial fluid containing products of pathometabolism into the blood stream within concentration gradient (by "dynamic equilibrium" in concentration of different substances in intracellular, interstitial and intravascular compartments). These effects are also related to release of receptors, their sensitization to their own neurohumoral regulation mechanisms, to insulin, in particular (as consequences, lower glucose tolerance, lower substrate glycation).
Conditions
- Hypercholesterolemia
- Hyperbilirubinemia
- Hyper IgE Syndrome
- Hyper Beta Lipoproteinemia
- Hyper Eosinophilic Syndrome
- Hyper-LDL-cholesterolemia
- Gout
- Diabetes
- Nervous System Diseases
- Neuromuscular Diseases
- Cardiovascular Diseases
- Urologic Diseases
Interventions
- PROCEDURE
-
plasma exchange with albumin
plasma exchange with albumin, two per week, 110% of the circulating plasma volume
- PROCEDURE
-
plasma exchange without albumin
plasma exchange without albumin, two per week, 110% of the circulating plasma volume
Sponsors & Collaborators
-
The Orenburg Regional Clinical Hospital
collaborator OTHER_GOV -
DNKOM LLC
collaborator OTHER -
Pirogov Russian National Research Medical University
collaborator OTHER -
National Medical Research Center for Rehabilitation and Balneology
lead OTHER
Principal Investigators
-
Ilmira Gilmutdinova · Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-05-12
- Primary Completion
- 2022-10-30
- Completion
- 2022-12-30
Countries
- Russia
Study Locations
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