Survey on metformin-induced vitamin B12 deficiency in patients with type 2 diabetes

Not Applicable

• Conditions: Type 2 diabetes

• Registration Number: JPRN-UMIN000019126
• Lead Sponsor: Kobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1)Is receiving vitamin B12 preparation including vitamin B12 supplements 2)Is receiving steroids, and gastrectomy (include segmentectomy and total resection, but not endoscopic mucosal resection) 3)Is pregnant, nursing, or planned to become pregnant 4)With malabsorption(chronic pancreatitis,inflammatory bowel disease and malabsorption syndrome) 5)With severe infection, pre or post surgery, and serious trauma,malignancy 6)With renal dysfunction (Serum Creatinine male: >= 1.5 mg/dL, female: >= 1.3 mg/dL) 7)Considered as inadequate by the investigator

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The corelation between the period of taking metformin and serum homocysteine or vitamin B12 level as the diagnostic index for vitamin B12 deficiency.

Secondary Outcome Measures

Name	Time	Method
1)The corelation between the daily dose of metformin and serum homocysteine or vitamin B12 level as the diagnostic index for vitamin B12 deficiency. 2)The corelation between the cumulative dose of metformin and serum homocysteine or vitamin B12 level. 3)The relationship between macrocytic anemia and serum homocysteine or vitamin B12 level.