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IRCT2015011614717N2 IRCT 2015-05-18 Vice-Chancellor for Research of Shiraz University of Medical Sciences Assessment of the effect of metformin on serum levels of homocysteine, folic acid, and vitamin B12 in patients with type 2 diabetes mellitus Comparison of serum levels of homocysteine, folic acid, and vitamin B12 in patients with type 2 diabetes mellitus before and after treatment with metformin 2011-12-06 anticipated 50 Complete https://irct.ir/trial/14266 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. N/A Diabetes mellitus type 2. Intervention 1: In the beginning patients followed diet regimen alone for three months. Intervention 2: 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.
public Doctor Fariba Karimi
Department of Internal Medicine, Namazee Hospital, Namazee Square, Zand Street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4316 karimif@sums.ac.ir, karimif2002@yahoo.com Shiraz University of Medical Sciences scientific Doctor Fariba Karimi
Department of Internal Medicine, Namazee Hospital, Namazee Square, Zand Street, Shiraz University of Medical Sciences, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7187793645 +98 71 3647 4316 karimif@sums.ac.irkarimif2002@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 30 years 75 years Both E11 Non insulin dependent diabetes mellitus Treatment - Drugs Treatment - Drugs In the beginning patients followed diet regimen alone for three months 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 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. 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. 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. Fasting blood sugar. Timepoint: In the beginning and then every 6 weeks. Method of measurement: Blood test by glucose dehydrogenase method. Two hours postprandial blood sugar. Timepoint: In the beginning and then every 6 weeks. Method of measurement: Blood test by glucose dehydrogenase method. 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. Glycated hemoglobin (HbA1c) level. Timepoint: In the beginning and 3 to 6 months after starting the study. Method of measurement: Direct enzymatic assay. Weight of the patients. Timepoint: In the beginning and 3 and 6 months after starting the study. Method of measurement: By standard stadiometer. 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. not registered yet not registered yet Vice-Chancellor for Research of Shiraz University of Medical Sciences Approved 2011-11-05 Shiraz University of Medical Sciences Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran Shiraz Iran (Islamic Republic of)