Effect of Vitamin D on serum levels and gene Expression of Enzymes Allodose Reductase, Glucosamine Transferase and Glutamine Fructose Amidotransferase in Type 2 Diabetes Patients
Determination of serum levels and gene expression of , aldose reductase, hexosamine transferase ,glutamine-fructose amidotransferase at the begining and end of the study
Design
This study was a double blind clinical trial in which two groups of 37 participants participated, both of whom were diabetic patients who had all the criteria for entering the study.
The first group received supplements and the second group of homogeneous diabetic patients were BMI for age and sex, who took placebo and were selected as controls.
. We used permuted random block method .
Settings and conduct
Stratified randomization was done using computer-generated
random numbers. Eligible participants were randomized to receive daily capsules of placebo or vitamin D in a double-blind fashion. All participants who visit Endocrinology and Metabolism Research Institute,
after an overnight fast, venous blood samples were taken at the beginning and at the end of the study. During the study both patients and researcher were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 35-65 years; Diabetic patients who take metformin and sulfonylureas and do not take supplemental drugs. with BMI less than 30 kg/m2. Exclusion criteria: Subjects on any anti-inflammatory medication; Patients on insulin therapy; Patients with renal disease; cancer; infectious diseases; pregnant women; Coronary artery disease and vitamin D supplementation
Intervention groups
Accidental assignment to intervention groups (vitamin D and control (medication), double-blinded
Parallel
Main outcome variables
Determine the serum levels of glucose, glycosylated hemoglobin and glutamine-fructose amidotransferase
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170813035665N2
Registration date:2019-06-12, 1398/03/22
Registration timing:retrospective
Last update:2019-06-12, 1398/03/22
Update count:0
Registration date
2019-06-12, 1398/03/22
Registrant information
Name
Mahnaz Zarei
Name of organization / entity
Tehran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3057
Email address
m-zarei@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-04-09, 1398/01/20
Actual recruitment start date
2018-12-06, 1397/09/15
Actual recruitment end date
2019-04-14, 1398/01/25
Trial completion date
2019-04-14, 1398/01/25
Scientific title
Effect of Vitamin D on serum levels and gene Expression of Enzymes Allodose Reductase, Glucosamine Transferase and Glutamine Fructose Amidotransferase in Type 2 Diabetes Patients
Public title
Effect of Vitamin D on Enzymes in type 2 Diabetes patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes who have35-65 years .
patients take oral hypoglycemic drugs metformin or sulphonylurea.
patients have been diagnosed with at least two years.
Patients do not take supplemental drugs.
patients with BMI less than 30 kg/m2
Exclusion criteria:
do not use vitamin D ,vitamin B6 supplements or diets at least 4-6 weeks before the intervention.
Age
From 35 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Actual sample size reached:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization was done using computer-generated
random numbers. Eligible participants were randomized to
receive daily tablets of placebo or vitamin D
in a double-blind fashion.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the investigator and patients were
blinded from the time of randomization until analysis was comleted.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National etics committee of biomedical research
Street address
floor 13, Department A ,Ministry of Health and Medical Education, Simaye Iran Ave Qods Town
City
Tehran
Province
Tehran
Postal code
1354619551
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.IAU.SRB.REC.1397.168
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
GFAT
Timepoint
Before and three months after intervention
Method of measurement
Elisa
2
Description
Aldose reductase
Timepoint
Before and three months after intervention
Method of measurement
Elisa
3
Description
Hexose amin transferase
Timepoint
Before and three months after intervention
Method of measurement
Elisa
4
Description
Glutamin Amido transferase gene expression
Timepoint
Before and three months after intervention
Method of measurement
Real time PCR
5
Description
Hexose amin transferase gene expression
Timepoint
Before and three months after intervention
Method of measurement
Real time PCR
6
Description
Aldose Reductase gene expression
Timepoint
Before and three months after intervention
Method of measurement
Real time PCR
Secondary outcomes
1
Description
Vitamin D
Timepoint
Before and three months after intervention
Method of measurement
Electrochemiluminesence
2
Description
calcium
Timepoint
Before and three months after intervention
Method of measurement
Espectrophotometry
3
Description
insulin
Timepoint
Before and three months after intervention
Method of measurement
Electrochemiluminesence
4
Description
A1C
Timepoint
Before and three months after intervention
Method of measurement
Chromatoghraphy
5
Description
TNF
Timepoint
Before and three months after intervention
Method of measurement
Elisa
6
Description
ages
Timepoint
Before and three months after intervention
Method of measurement
Elisa
7
Description
PAI
Timepoint
Before and three months after intervention
Method of measurement
Elisa
8
Description
ykl-40
Timepoint
Before and three months after intervention
Method of measurement
Elisa
9
Description
TG
Timepoint
Before and three months after intervention
Method of measurement
Espectrophotometry
10
Description
cholestrol
Timepoint
Before and three months after intervention
Method of measurement
Espectrophotometry
11
Description
HDL
Timepoint
Before and three months after intervention
Method of measurement
Espectrophotometry
12
Description
LDL
Timepoint
Before and three months after intervention
Method of measurement
Espectrophotometry
13
Description
Diastolic and systolic blood pressure
Timepoint
Before and three months after intervention
Method of measurement
Sphygmomanometer and Stethoscope will be used to measure the blood pressure
14
Description
BMI
Timepoint
Before and three months after intervention
Method of measurement
the formula for BMI is weight in kilograms divided by height in meters squared
15
Description
Insulin resistance
Timepoint
Before and three months after intervention
Method of measurement
HOMA-IR
16
Description
weight
Timepoint
Before and three months after intervention
Method of measurement
seca scale in kilograms
17
Description
Waist
Timepoint
Before and three months after intervention
Method of measurement
Band meters in cm
18
Description
IL6
Timepoint
Before and three months after intervention
Method of measurement
Elisa
Intervention groups
1
Description
Intervention group 1: receive 100 micro gram of vitamin D daily for 3 months
Category
Treatment - Drugs
2
Description
Intervention group 2: receive 100 micro gram of placebo daily for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center, Endocrinology and Metabolism Research Institute
Full name of responsible person
Dr.Rajab
Street address
Clinic of Diabetes, West 17 Shahrivar, North Kargar َAve, Amir Abad City Tehran
City
Tehran
Province
Tehran
Postal code
1354619551
Phone
+98 21 4293 3057
Email
mahnazzareei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.jalali
Street address
Deptartment of Nutrition&dieticsTehran University of Medical Sciences, Poursina avenue
City
Tehran
Province
Tehran
Postal code
1354619551
Phone
+98 21 4293 3057
Email
jalalimahmoud@hotmail.com
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
Mahnaz zarei
Position
PhD Student of Biochemistry
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Tehran University of Medical Sciences,Poursina street
City
تهران
Province
Tehran
Postal code
1354619551
Phone
+98 42933057
Email
mahnazzareei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz zarei
Position
Msc
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Tehran University of Medical Sciences, Poursina avenue
City
Tehran
Province
Tehran
Postal code
1354619551
Phone
+98 21 4293 3057
Email
mahnazzareei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Zarei
Position
student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Tehran University of Medical Sciences, Poursina avenue
City
Tehran
Province
Tehran
Postal code
1354619551
Phone
+98 21 4293 3057
Email
mahnazzareei@yahoo.com
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
Dissatisfaction of participant
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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