Comparison of serum levels of homocysteine, folic acid, and vitamin B12 in patients with type 2 diabetes mellitus before and after treatment with metformin
This clinical trial was conducted with the aim of comparison of serum levels of homocysteine, folic acid and vitamin B12 before and after 3 months treatment with metformin. Fifty patients with type 2 diabetes mellitus who referred to endocrine clinic participated in this survey. Inclusion criteria were: age range of 30 to 75 years old; negative history of previous diabetic ketoacidosis; recent diagnosis of type 2 diabetes mellitus; fasting blood sugar 135 milligram per deciliter or more and 2 hours postprandial blood sugar 180 milligram per deciliter or more. Exclusion criteria included: not using drugs with effect on folate and vitamin B12 metabolism; pregnancy; history of surgery on gastrointestinal tract; impaired renal function; class III or more of congestive heart failure; hypothyroidism. In the beginning the patients followed diet regimen for 3 months and their blood sugar was checked at 6 weeks intervals then treatment with metformin from a minimum dose of 500 milligrams daily to maximum dose of 2500 milligrams daily, according to their blood sugar level, was started. After 3 and 6 months of starting the study their weight was measured and their blood samples were taken for measurement of homocysteine, folic acid, vitamin B 12, lipids and Glycated hemoglobin (HbA1c) levels. Also, their height was measured in the beginning for calculation of their Body Mass Index (BMI)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011614717N2
Registration date:2015-05-18, 1394/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-18, 1394/02/28
Registrant information
Name
Fariba Karimi
Name of organization / entity
Shiraz University of Meical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3624 6096
Email address
karimif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-12-06, 1390/09/15
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of serum levels of homocysteine, folic acid, and vitamin B12 in patients with type 2 diabetes mellitus before and after treatment with metformin
Public title
Assessment of the effect of metformin on serum levels of homocysteine, folic acid, and vitamin B12 in patients with type 2 diabetes mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age range of 30 to 75 years old; type 2 of diabetes mellitus; absent previous history of diabetic ketoacidosis; fasting blood sugar 135 milligrams per deciliter or more and 2 hours postprandial blood sugar 180 milligrams per deciliter or more. Exclusion criteria: consumption of vitamin B12, folic acid or drugs with effects on folate metabolism (such as: anticonvulsants, antirheumatologic, and antineoplastic medications); renal function defect (serum creatinine level greater than 1.3 milligram in deciliter) ; pregnancy or trying to become pregnant; history of surgery on gastrointestinal tract (stomach or ileum) ; history of hypothyroidism; class III or more of congestive heart failure presence of malignant disorders; presence of psychiatric diseases; treatment with antibiotics; uncontrolled blood sugar during the intervention
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
not registered yet
Secondary trial Id
not registered yet
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Approval date
2011-11-05, 1390/08/14
Ethics committee reference number
90/325855
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type 2
ICD-10 code
E11
ICD-10 code description
Non insulin dependent diabetes mellitus
Primary outcomes
1
Description
Serum level of homocysteine
Timepoint
In the beginning and 3 to 6 months after starting the intervention
Method of measurement
Measurement of serum level of homocysteine by enzyme immunoassay method
2
Description
Serum level of folic acid
Timepoint
In the beginning and 3 to 6 months after starting the intervention
Method of measurement
Measurement of serum level of folic acid by radioimmunoassay method
3
Description
Serum level of vitamin B12
Timepoint
In the beginning and 3 to 6 months after starting the intervention
Method of measurement
Measurement of serum level of vitamin B12 by radioimmunoassay method
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
In the beginning and then every 6 weeks
Method of measurement
Blood test by glucose dehydrogenase method
2
Description
Two hours postprandial blood sugar
Timepoint
In the beginning and then every 6 weeks
Method of measurement
Blood test by glucose dehydrogenase method
3
Description
Lipid profile
Timepoint
In the beginning and then 3 and 6 months after starting the study
Method of measurement
Blood test by cholesterol oxidase/ peroxidase and glycerol phosphate oxidase/ peroxidase and direct enzymatic methods
4
Description
Glycated hemoglobin (HbA1c) level
Timepoint
In the beginning and 3 to 6 months after starting the study
Method of measurement
Direct enzymatic assay
5
Description
Weight of the patients
Timepoint
In the beginning and 3 and 6 months after starting the study
Method of measurement
By standard stadiometer
6
Description
Body mass index
Timepoint
In the beginning and 3 and 6 months after starting the study
Method of measurement
By the formula: weight in kilograms divided by height in meters squared
Intervention groups
1
Description
In the beginning patients followed diet regimen alone for three months
Category
Treatment - Drugs
2
Description
After 3 months of diet regimen alone, treatment with metformin with a minimum dose of 500 milligrams daily to a maximum dose of 2500 milligrams per day in three divided doses by mouth, according to their blood sugar, was started. In this study 500 milligrams tablets of metformin which manufactured by Osveh company were used
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Motahari Clinic of Shiraz University of Mediacl Sciences
Shaheed Faghihi Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Doctor Fariba Karimi
Street address
Iran, Shiraz, Zand Street, Shaheed Faghihi Hospital, Shaheed Faghihi Clinic, Clinic of Internal Medicine, Second Floor
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Shiraz University of Medical Sciences
Full name of responsible person
Doctor Basyr Hashemi
Street address
Department of Vice-Chancellor for Research of Shiraz University of Medical Sciences, 7th Floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
CT-87-4021
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Fariba Karimi
Position
Internist with subspecialty in Endocrinology and Metabolism, Assistant professor of Shiraz Universit
Other areas of specialty/work
Street address
Department of Internal Medicine, Namazee Hospital, Namazee Square, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4316
Fax
+98 71 3647 4316
Email
karimif@sums.ac.ir, karimif2002@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Fariba Karimi
Position
Internist with subspecialty in Endocrinology and Metabolism, Assistant professor of Shiraz Universit
Other areas of specialty/work
Street address
Department of Internal Medicine, Namazee Hospital, Namazee Square, Zand Street, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
7187793645
Phone
+98 71 3647 4316
Fax
+98 71 3647 4316
Email
karimif@sums.ac.irkarimif2002@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Fariba Karimi
Position
Internist with subspecialty in Endocrinology and Metabolism, Assistant professor of Shiraz Universit
Other areas of specialty/work
Street address
Department of Internal Medicine, Namazee Hospital, Namazee Square, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
۷۱۸۷۷۹۳۶۴۵
Phone
+98 71 3624 6096
Fax
+98 71 3647 4316
Email
karimif@sums.ac.ir, karimif2002@yahoo.com
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)