NCT03877523

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

March 11, 2019

Last Update Submit

March 19, 2019

Conditions

Diabetes Mellitus, Type 2Diabetes Complications

Keywords

CocarnitDiabetes MellitusMacrophages polarization

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    30 days

Study Arms (1)

Cocarnit

EXPERIMENTAL

disodium adenosine triphosphate trihydrate 10mg, cocarboxylase 50mg, cyanocobalamin 500mg and nicotinamide 20mg

Dietary Supplement: Cocarnit

Interventions

CocarnitDIETARY_SUPPLEMENT

a metabolic complex

Cocarnit

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Refusal to take the preparation during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Atherosclerosis Research

Moscow, 121609, Russia

Location

Related Publications (4)

  • Shoelson SE, Lee J, Goldfine AB. Inflammation and insulin resistance. J Clin Invest. 2006 Jul;116(7):1793-801. doi: 10.1172/JCI29069.

    PMID: 16823477BACKGROUND

  • Tilg 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.

    PMID: 18235842BACKGROUND

  • Cave 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.

    PMID: 18203961BACKGROUND

  • Gratchev 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.

    PMID: 16920487BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes ComplicationsDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alexander N Orekhov, DSc, Prof

    Institute for Atherosclerosis Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 15, 2019

Study Start

October 3, 2018

Primary Completion

November 18, 2018

Study Completion

December 20, 2018

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)