Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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.
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.
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