Clinical trial NCT04897113: 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
Official title: Multicenter, Open, Prospective, Randomized Trial 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Keywords: plasmapheresis
plasma exchange
albumin
biomarkers of aging
age-related diseases
Lead sponsor: National Medical Research Center for Rehabilitation and Balneology
Sponsor class: OTHER
Collaborators: name: The Orenburg Regional Clinical Hospital
name: DNKOM LLC
name: Pirogov Russian National Research Medical University
First posted: 2021-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: 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.

Non-inclusion Criteria:

* 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.

Primary outcomes:
measure: Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count
timeFrame: 1 month
Secondary outcomes:
measure: Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count
timeFrame: 17 (+/- 2) days
measure: Dynamics summary for aging biomarkers' values assessed by a patient's complete blood count
timeFrame: 1 month
measure: Dynamics summary for aging biomarkers' values assessed by a patient's blood serological test
timeFrame: 1 month
measure: Dynamics summary for aging biomarkers' values assessed by a patient's coagulation test
timeFrame: 1 month
measure: Dynamics of results according to the method of "phenotypic age"
timeFrame: 1 month
measure: Dynamics of results according to the method of biological age
timeFrame: 1 month
measure: Dynamic pattern according to ECG results
timeFrame: 1 month
measure: Dynamic pattern according to results of vascular ultrasonography
timeFrame: 1 month
measure: SF-36 scale
timeFrame: 1 month
measure: HAM questionnaire
timeFrame: 1 month
measure: scales of the "Health-Promoting Lifestyle Profile"
timeFrame: 1 month
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia
city: Orenburg
country: Russian Federation
facility: Orenburg regional clinical blood transfusion station
Study officials:
affiliation: Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia
name: Ilmira Gilmutdinova
role: STUDY_CHAIR
References: