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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2022-12-30

Brief Summary

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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).

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Detailed Description

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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.

One of the initial approaches of anti-ageing therapy is detoxification, reocorrection and immunocorrection. 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).

Thus, at this stage, experts assess effectiveness and organize data of existing prevention methods for premature aging and correction of aging biomarkers, as well as develop comprehensive programs for drug-free and pharmacological intervention. Introduction of the body detoxification method based on extracorporeal hemocorrection (developed in FGBU Russian Scientific Center for Medical Rehabilitation and Balneology of Ministry of Health of Russian Federation) may extend the range of effective and safe methods within such programs, as well as lower patients' biological age and, thus, lower risks of developing age-related diseases, decrease number of disability cases, which can contribute to life prolonging and improvement of its quality.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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plasmapheresis with albumin compensation

a course of hardware plasmapheresis procedures with replacement by colloidal (5% albumin solution) and crystalloid solutions (saline) in a ratio of 1: 3

Group Type EXPERIMENTAL

plasma exchange with albumin

Intervention Type PROCEDURE

plasma exchange with albumin, two per week, 110% of the circulating plasma volume

plasmapheresis without albumin compensation

a course of hardware plasmapheresis procedures without replacement by albumin solution, only crystalloid solutions (saline).

Group Type EXPERIMENTAL

plasma exchange without albumin

Intervention Type PROCEDURE

plasma exchange without albumin, two per week, 110% of the circulating plasma volume

Interventions

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plasma exchange with albumin

plasma exchange with albumin, two per week, 110% of the circulating plasma volume

Intervention Type PROCEDURE

plasma exchange without albumin

plasma exchange without albumin, two per week, 110% of the circulating plasma volume

Intervention Type PROCEDURE

Other Intervention Names

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plasmapheresis with albumin plasmapheresis without albumin

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent form.
* Men and women aged 40-55.
* Body mass index \<30 kg / m2.
* Level increase of one or several aging markers.
* Understanding of requirements for study participants, written consent to participate in the study (including volunteer's consent for his/her health information related to the study to be used and passed on) and to perform procedures outlined in study protocol.
* Negative pregnancy test for women of childbearing potential.

* Refusal to participate in the study.
* Any health conditions that, according to investigators, might prevent volunteers from participating in the study.
* Mental disorders, past medical history included.
* 10 + alcohol units per week (one alcohol unit equals 0,5 l of beer, 200 ml of wine or 50 ml of hard liquors) or any records of alcohol addiction.
* Drug addiction, chemical abuse.
* Pregnancy or breastfeeding.
* Past medical history of severe allergic reactions.
* General contraindications to plasmapheresis procedures.
* Any other health conditions or reasons that, according to investigators, might increase risks for participants or reduce the likelihood of results needed to meet the study goals.

Exclusion Criteria

* Voluntary refusal to participate in the study.
* Investigator doctor's decision on participant's exclusion for this participant's own benefit.
* Participant refuses to cooperate with investigator or is undisciplined.
* In case participant misses one or several study procedures or follow-up visits.
* Development of severe adverse reactions or severe diseases/conditions unrelated to the study, requiring withdrawal from therapy.
* Positive pregnancy test.

Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes