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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015011614717N2
Enrollment
50
Registered
2015-05-18
Start date
2011-12-06
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2. Non insulin dependent diabetes mellitus

Interventions

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 millig
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 th

Sponsors

Vice-Chancellor for Research of Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDoctor Fariba Karimi

Shiraz University of Medical Sciences

karimif@sums.ac.ir, karimif2002@yahoo.com+98 71 3647 4316

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026