Diabetes Mellitus, Type 2COMP-DMNCT03877523
Cocarnit Effects on Macrophages Polarization
A study testing Cocarnit in people with Diabetes Mellitus, Type 2 and Diabetes Complications, run by Institute for Atherosclerosis Research, Russia at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Complications
- What is being tested?
- Cocarnit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 3 Oct 2018to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus newly-diagnosed (for group 1)
- Type 2 diabetes and diabetic polyneuropathy (for group 2)
- Availability of informed consent to participate in the study
Who cannot join
- Refusal to sign informed consent to participate in the study
- Presence of chronic diseases that require constant medication, except preparations for the correction of diabetes
- Individual intolerance to the preparation
- Infectious disease or fever during the period of inclusion
- Refusal to take the preparation during the study
- Non-compliance with inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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:
- Newly-diagnosed type-2 DM - 20 participants;
- Type-2 DM with polyneuropathy - 20 participants.
The following measurements are held:
- 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.
- 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.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Complications
- Being tested
- Cocarnit
- Keywords
- Cocarnit, Diabetes Mellitus, Macrophages polarization
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocarnitDietary supplement
a metabolic complex
| Study group | Role | What they receive |
|---|---|---|
| Cocarnit | Experimental | disodium adenosine triphosphate trihydrate 10mg, cocarboxylase 50mg, cyanocobalamin 500mg and nicotinamide 20mg Receives: Dietary Supplement: Cocarnit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in macrophages activation after single Cocarnit administration
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.
Measured: 4 hours
Change in macrophages activation after 30-days Cocarnit administration
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start3 Oct 2018
- Primary completion18 Nov 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Atherosclerosis Research, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander N Orekhov, DSc, Prof, Principal investigator, Institute for Atherosclerosis Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877523
- Sponsor's protocol ID
- IAR-CS1
- Acronym
- COMP-DM
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shoelson SE, Lee J, Goldfine AB. Inflammation and insulin resistance. J Clin Invest. 2006 Jul;116(7):1793-801. doi: 10.1172/JCI29069.
PubMed 16823477Tilg H, Moschen AR. Inflammatory mechanisms in the regulation of insulin resistance. Mol Med. 2008 Mar-Apr;14(3-4):222-31. doi: 10.2119/2007-00119.Tilg.
PubMed 18235842Cave MC, Hurt RT, Frazier TH, Matheson PJ, Garrison RN, McClain CJ, McClave SA. Obesity, inflammation, and the potential application of pharmaconutrition. Nutr Clin Pract. 2008 Feb;23(1):16-34. doi: 10.1177/011542650802300116.
PubMed 18203961Gratchev A, Kzhyshkowska J, Kothe K, Muller-Molinet I, Kannookadan S, Utikal J, Goerdt S. Mphi1 and Mphi2 can be re-polarized by Th2 or Th1 cytokines, respectively, and respond to exogenous danger signals. Immunobiology. 2006;211(6-8):473-86. doi: 10.1016/j.imbio.2006.05.017. Epub 2006 Jul 21.
PubMed 16920487
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cocarnit on Macrophages Polarization in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT03877523
- Acronym / sponsor ID
- COMP-DM / IAR-CS1
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Complications
- Keywords
- Cocarnit, Diabetes Mellitus, Macrophages polarization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institute for Atherosclerosis Research, RussiaUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 18 Nov 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Newly-diagnosed type-2 DM - 20 participants;
- Type-2 DM with polyneuropathy - 20 participants.
The following measurements are held:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cocarnit | Experimental | Dietary Supplement: Cocarnitdisodium adenosine triphosphate trihydrate 10mg, cocarboxylase 50mg, cyanocobalamin 500mg and nicotinamide 20mg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus newly-diagnosed (for group 1)
- Type 2 diabetes and diabetic polyneuropathy (for group 2)
- Availability of informed consent to participate in the study
Key exclusion criteria (6 listed)
- Refusal to sign informed consent to participate in the study
- Presence of chronic diseases that require constant medication, except preparations for the correction of diabetes
- Individual intolerance to the preparation
- Infectious disease or fever during the period of inclusion
- Refusal to take the preparation during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocarnita metabolic complex | Dietary supplement | Cocarnit |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Background: PubMed 16823477Shoelson SE, Lee J, Goldfine AB. Inflammation and insulin resistance. J Clin Invest. 2006 Jul;116(7):1793-801. doi: 10.1172/JCI29069.
- Background: PubMed 18235842Tilg H, Moschen AR. Inflammatory mechanisms in the regulation of insulin resistance. Mol Med. 2008 Mar-Apr;14(3-4):222-31. doi: 10.2119/2007-00119.Tilg.
- Background: PubMed 18203961Cave MC, Hurt RT, Frazier TH, Matheson PJ, Garrison RN, McClain CJ, McClave SA. Obesity, inflammation, and the potential application of pharmaconutrition. Nutr Clin Pract. 2008 Feb;23(1):16-34. doi: 10.1177/011542650802300116.
- Background: PubMed 16920487Gratchev A, Kzhyshkowska J, Kothe K, Muller-Molinet I, Kannookadan S, Utikal J, Goerdt S. Mphi1 and Mphi2 can be re-polarized by Th2 or Th1 cytokines, respectively, and respond to exogenous danger signals. Immunobiology. 2006;211(6-8):473-86. doi: 10.1016/j.imbio.2006.05.017. Epub 2006 Jul 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander N Orekhov, DSc, Prof principal investigator
Institute for Atherosclerosis Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocarnit in people with Diabetes Mellitus, Type 2 and Diabetes Complications, run by Institute for Atherosclerosis Research, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in macrophages activation after single Cocarnit administration (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03877523, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.