Assessment of the effect of metformin on serum levels of homocysteine, folic acid, and vitamin B12 in patients with type 2 diabetes mellitus
- Conditions
- Diabetes mellitus type 2.Non insulin dependent diabetes mellitus
- Registration Number
- IRCT2015011614717N2
- Lead Sponsor
- Vice-Chancellor for Research of Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time 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.