Cocarnit Effects on Macrophages Polarization (COMP-DM)

March 19, 2019 updated by: Institute for Atherosclerosis Research, Russia

Effects of Cocarnit on Macrophages Polarization in Type 2 Diabetic Patients

Cocarnit is a metabolic complex containing disodium adenosine triphosphate trihydrate, cocarboxylase, cyanocobalamin and nicotinamide.

Aim: To test the effects of Cocarnit on pro- and anti-inflammatory activation of blood-derived monocytes-macrophages from Type 2 diabetic patients.

Study design: Measurements of stimulated and basal secretion of TNF-alpha and CCl-18 before and at 2 and 4 hours after single intramuscular administration of Cocarnit at first day and after 30 days of follow-up in 40 Type 2 diabetic patients with/without polyneuropathy.

Methods: The profile of monocyte polarization was determined in vitro in primary cell culture of blood-derived monocytes-macrophages after pro-inflammatory stimulation by bacterial lipopolysaccharide and after anti-inflammatory stimulation by interleukin-4, according to tumor necrosis factor (TNF) and CCL18 chemokine secretion, respectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetes mellitus (DM) is the most common endocrine disease, and its social significance is associated with early disability and high mortality. Indicators of diabetes mellitus decompensation are its chronic complications, the most common one is a diabetic polyneuropathy. In recent years a large number of papers demonstrate the role of the chronic inflammatory process in the development of type 2 DM. Macrophages play a key role in the development of the inflammatory response. Macrophages are the main cells producing pro-inflammatory cytokines, which cause a cascade of reactions leading to the development of insulin resistance, that is the important factor of the pathogenesis of type 2 DM. There are two main types of activation of macrophages under the influence of T-helper cells 1 and 2. The first type is classical activation of macrophages that is a response to pro-inflammatory stimuli, such as interferon-gamma or lipopolysaccharide. Classically activated macrophages are well studied and characterized by the secretion of reactive oxygen species and pro-inflammatory cytokines such as TNF-alpha, interleukins 1,6,12. The second type is alternative activation of macrophages that is the result of the influence of anti-inflammatory cytokines, such as interleukins 4,10,13 or anti-inflammatory mediators, for example, glucocorticoids. The result of alternative activation of macrophages is the expression of anti-inflammatory cytokines such as antagonist receptor interleukin 1, interleukin 10, CCL18, haptoglobin receptor CD163, scavenger receptor type1.

Cocarnit is a metabolic complex containing disodium adenosine triphosphate trihydrate 10mg, cocarboxylase 50mg, cyanocobalamin 500mg and nicotinamide 20mg.

The aim of the present study is to test the effects of Cocarnit on pro- and anti-inflammatory activation of blood-derived monocytes-macrophages from Type 2 diabetic patients.

The profile of monocyte polarization was determined in vitro in primary cell culture of blood-derived monocytes-macrophages after pro-inflammatory stimulation by bacterial lipopolysaccharide and after anti-inflammatory stimulation by interleukin-4, according to tumor necrosis factor (TNF) and CCL18 chemokine secretion, respectively.

Study design: Open label study included 40 Type 2 diabetic patients divided into two groups:

  1. Newly-diagnosed type-2 DM - 20 participants;
  2. Type-2 DM with polyneuropathy - 20 participants.

The following measurements are held:

  1. stimulated and basal secretion of TNF-alpha before and at 2 and 4 hours after single intramuscular administration of Cocarnit at first day and 30 days of follow-up.
  2. stimulated and basal secretion of CCl-18 before and at 2 and 4 hours after single intramuscular administration of Cocarnit at first day and after 30 days of follow-up.

The research database is compiled upon completion of the study and then a statistical analysis of the results is carried out.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 121609
        • Institute for Atherosclerosis Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type 2 diabetes mellitus newly-diagnosed (for group 1)
  2. Type 2 diabetes and diabetic polyneuropathy (for group 2)
  3. Availability of informed consent to participate in the study

Exclusion Criteria:

  1. Refusal to sign informed consent to participate in the study
  2. Presence of chronic diseases that require constant medication, except preparations for the correction of diabetes
  3. Individual intolerance to the preparation
  4. Infectious disease or fever during the period of inclusion
  5. Refusal to take the preparation during the study
  6. Non-compliance with inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cocarnit
disodium adenosine triphosphate trihydrate 10mg, cocarboxylase 50mg, cyanocobalamin 500mg and nicotinamide 20mg
Dietary supplement: Cocarnit
a metabolic complex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in macrophages activation after single Cocarnit administration
Time Frame: 4 hours
Measurement of serum-induced basal and stimulated by bacterial lipopolysaccharide secretion of TNF-alpha and basal and stimulated by IL-4 secretion of CCL-18 in primary cell culture of blood-derived monocytes-macrophages before and after 2 and 4 hours of Cocarnit administration. Changes are expressed in % of baseline secretion before the preparation administration.
4 hours
Change in macrophages activation after 30-days Cocarnit administration
Time Frame: 30 days
Measurement of serum-induced basal and stimulated by bacterial lipopolysaccharide secretion of TNF-alpha and basal and stimulated by IL-4 secretion of CCL-18 in primary cell culture of blood-derived monocytes-macrophages after 30 days of Cocarnit administration. Changes are expressed in % of baseline secretion before the preparation administration.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Atherosclerosis Research, Russia

Investigators

  • Principal Investigator: Alexander N Orekhov, DSc, Prof, Institute for Atherosclerosis Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2018

Primary Completion (Actual)

November 18, 2018

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAR-CS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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