Evaluation of effects of vitamin C supplementation on LCAT (lecithin-cholesterol Acyltransferas) activity compared to plcebo in patients with type 2 diabetes
Investigate of effects of vitamin C supplementation on LCAT activity level in patients with type 2 diabetes in diabetic clinic of Imam khomeini hospital
This study will be conducted in diabetes clinic of imam Khomeini hospital in Tehran university of medical sciences. All diabetic patients enrolled in the study according to inclusion criteria. Informed consent will be taken of the patients, then demographic and anthropocentric data will be registered, and primary lab data will be taken from the patients. Then the patients Randomized in two groups. Group 1 :will be received vitamin c 500 mg daily for 2 month, group 2: will be received placebo as group 1 for 2 months
After 2 months ,blood samples will be taken from both groups and lab data and LCAT activity will be measured and analyzed .
Participants/Inclusion and exclusion criteria
Inclusion criteria: type 2 diabetes,age more than 30 year.
Exclusion criteria : pregnancy,vitamin use,glucocorticoid use,renal failure,heart failure ,smoker,liver failure,malignancy,acute inflammation and infections, hypersensitivity to vitamin c ,antioxidant drug use ,hypothyroidism, renal stone.
Intervention groups
Prescription vitamin c and placebo randomly in two groups.
Main outcome variables
LCAT level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160811029306N2
Registration date:2020-11-11, 1399/08/21
Registration timing:registered_while_recruiting
Last update:2020-11-11, 1399/08/21
Update count:0
Registration date
2020-11-11, 1399/08/21
Registrant information
Name
Manouchehr Nakhjavani
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 8671
Email address
nakhjavanim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-05, 1399/08/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of vitamin C supplementation on LCAT (lecithin-cholesterol Acyltransferas) activity compared to plcebo in patients with type 2 diabetes
Public title
vitamin c in diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Type2 diabetes
More than 2 years history of type2 diabetes
Exclusion criteria:
pregnancy
vitamin supplementation
glucocorticoid use
renal failure
history of heart failure
smoking
liver failure
malignancy
acute inflammation and infection
antioxidant drugs
allergy to vitamin c
hypothyroidism
renal stone
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed via random allocation software and patientS will be categorized into vitamin c user and placebo user.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. Both participants and investigator are blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam Khomeini hospital complex, tehran University of Medical Sciences
Street address
No 20, keshavarz Blvd ,Imam khomeini hospital
City
Tehran
Province
Tehran
Postal code
1419733147
Approval date
2020-10-14, 1399/07/23
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.263
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
LCAT( lecithin-cholestrol Acyltransferas)
Timepoint
Blood sample will be taken before and 2 months after treatment with vitamin c .
Method of measurement
LCAT will be measured by spectrophotometric assay
2
Description
HbA1c
Timepoint
Blood sample will be taken before and 2 months after treatment with vitamin c .
Method of measurement
Hb A1C will be measured by electrophoresis
3
Description
High Density Cholesterol (HDL)
Timepoint
Blood sample will be taken before and 2 months after treatment with vitamin c .
Method of measurement
HDL will be measured by Direct Enzymatic.
4
Description
Low Density Cholesterol (LDL)
Timepoint
Blood sample will be taken before and 2 months after treatment with vitamin c .
Method of measurement
LDL will be measured by Direct Enzymatic
5
Description
Insulin
Timepoint
Blood sample will be taken before and 2 months after treatment with vitamin c .
Method of measurement
Insulin will be measured by Chemiluminescence immunoassay.
6
Description
triglyceride (TG)
Timepoint
Blood sample will be taken before and 2 months after treatment with vitamin c .
Method of measurement
TG will be measured by enzymatic (GPO-POD) method.
7
Description
Fasting Blood Glucose (FBS)
Timepoint
Blood sample will be taken before and 2 months after treatment with vitamin c .
Method of measurement
FBS will be measured by enzymatic (GOD) method.
8
Description
Creatinine (Cr)
Timepoint
Blood sample will be taken before and 2 months after treatment with vitamin c .
Method of measurement
Cr will be measured by photomrtric method.(PICRATE/KINETC)
9
Description
Aspartate transaminase (AST)
Timepoint
Blood sample will be taken before and 2 months after treatment with vitamin c .
Method of measurement
AST will be measured by enzymatic method.
10
Description
Alanine transaminase (ALT)
Timepoint
Blood sample will be taken before and 2 months after treatment with vitamin c .
Method of measurement
ALT will be measured by enzymatic method.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral vitamin c supplement
Category
Prevention
2
Description
Control group: Placebo
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes clinic of Imam khomeini hospital
Full name of responsible person
manouchehr nakhjavani
Street address
No 20, keshavarz Blvd ,Imam khomeini hospital compelx ,Diabetes Clinic.
City
Tehran
Province
Tehran
Postal code
1419733147
Phone
+98 21 6119 1294
Email
nakhjavanim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice Chancellor for medical sciences
Street address
Keshavarz Blvd , Qods Town
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
manouchehr nakhjavani
Position
Endocrinology and metabolism
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 20, keshavarz Blvd ,Imam khomeini hospital compelx ,Vali asr hospital
City
Tehran
Province
Tehran
Postal code
1419733147
Phone
+98 21 61190
Email
nakhjavanim@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
manouchehr nakhjavani
Position
Endocinology and metabolism
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 20, keshavarz Blvd ,Imam khomeini hospital compelx ,Vali asr hospital
City
Tehran
Province
Tehran
Postal code
1419733147
Phone
+98 21 61190
Email
nakhjavanim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Manouchehr Nakhjavani
Position
endocrinology and metabolism
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 21,Vali asr hospital, keshavarz Bolvd, tehran ,Iran
City
tehran
Province
Tehran
Postal code
1419733147
Phone
+98 21 61190
Email
nakhjavanim@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
patients data is confident, I don't intend to publish the participants information file.