The effects of choline, magnesium and combined choline and magnesium supplementation on the components of inflammatory and coagulation markers in patients with type 2 diabetes mellitus
Determination and Comparison of the Effects of Cholin, Magnesium and Co-Choline and Magnesium on Components of Inflammatory and Coagulant factors in Type 2 Diabetic Patients
Design
parallel randomized controlled double blinded trial with a sample size of 80 people
Settings and conduct
The practical stages of the study are carried out in Tabriz . Patients with type 2 diabetes are selected with an endocrinologist diagnosis. Patients and researcher are blind.
Participants/Inclusion and exclusion criteria
Men and women with type 2 diabetes aged between 30-60 years. Patients who control their diabetes by glucose lowering tablets and do not use insulin.
Intervention groups
Qualified patients will be randomly divided into four groups of: 1- Choline supplement, 2- Magnesium supplement, 3- Co Choline and Magnesium, and 4- Placebo.
The effects of choline, magnesium and combined choline and magnesium supplementation on the components of inflammatory and coagulation markers in patients with type 2 diabetes mellitus
Public title
The effects of combined choline and magnesium supplementation in patients with type 2 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with type 2 diabetes
Men and women aged 60-30 years
Patients who their diabetes have been controlled by glucose lowering tablets
BMI=25-35 kg/m2
Exclusion criteria:
Unwillingness to cooperate
patients with inflammatory diseases, allergy, MS, kidney, liver, thyroid diseases
Use of insulin and corticosteroids and non-steroidal anti-inflammatory drugs and hormonal products
Changes in diet and physical activity, and type or dosage of medications used during the study
Pregnancy and breastfeeding
Tobacco and supplement use
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly divided into 4 groups of magnesium, choline, co-choline-magnesium and placebo supplementation. The packet method will be used for administering supplements and placebo to selected individuals; The randomization sequence is written in packets and will be delivered by a third person who is not aware of their content. So the investigator and the participants will not know which group they belong.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of the type of the intervention they receive. In order to blind patients, capsules identical to the supplements are prescribed for the control group. Each patient receive 3 capsules per day; group 1, one capsule of magnesium and two capsules of choline, group 2, 3 capsules of placebo, group 3, 1 magnesium capsule and two placebo capsules, and group 4, one placebo capsule and two capsules of choline. Also, a scientist who perform assessment of results and data analysis is also unaware of the type of the intervention each person receives.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2018-01-21, 1396/11/01
Ethics committee reference number
IR.TBZMED.REC.1396.945
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fast Blood Sugar
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
Enzymatic with Commercial Kits
2
Description
hemoglobin A1C
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
ELISA with Commercial Kits
3
Description
insulin
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
ELISA
4
Description
Triglyceride
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
Enzymatic
5
Description
Total Cholesterol
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
Enzymatic
6
Description
HDL-Cholesterol
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
Enzymatic
7
Description
LDL-Cholesterol
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
Enzymatic
8
Description
Interleukin-6 (IL-6)
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
ELISA
9
Description
vascular cell adhesion molecule 1 (VCAM-1)
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
ELISA
10
Description
Plasminogen activator inhibitor-1(PAI-1)
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
ELISA
11
Description
Tissue plasminogen activator(tPA)
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Blood Pressure
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
Digital Barometer
2
Description
weight
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
Scale
3
Description
Height
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
meter
4
Description
Body mass index(BMI)
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
Computing
5
Description
Fat percent
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
Bio impedance set
6
Description
waist circumference
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
meter
7
Description
Hip circumference
Timepoint
before the intervention and 60 days after the start of the intervention
Method of measurement
meter
Intervention groups
1
Description
Intervention group: 1 capsule of 500 mg of magnesium and 2 capsules of 500 mg of placebo per day for 60 days (Nano Kimia Health Co.)
Category
Treatment - Drugs
2
Description
Intervention group: 2 capsule of 500 mg of choline and 1 capsules of 500 mg of placebo per day for 60 days (Nano Kimia Health Co.)
Category
Treatment - Drugs
3
Description
Intervention group: 2 capsules of 500 milligrams of choline and 1 capsule of 500 mg of magnesium per day for 60 days (Nano Kimia Health Co.)
Category
Treatment - Drugs
4
Description
Control group: 3 capsules of 500 mg of placebo per day for 60 days (Nano Kimia Health Co.)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Samaneh Rashvand
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Email
rashvands@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Tarighat Esfanjani
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
tarighata@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Dean for research and technology Tabriz University of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Tarighat Esfanjani
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
tarighata@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Tarighat Esfanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
tarighata@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samaneh Rashvand
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
Rashvands@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available