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Metformin Use and Vitamin B12 Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136512
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : July 31, 2013
Information provided by (Responsible Party):
Northwell Health

Brief Summary:
The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.

Condition or disease
Vitamin B12 Deficiency Type 2 Diabetes Mellitus

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Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Metformin Use and Vitamin B12 Deficiency
Study Start Date : August 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

metformin use
Patients with type 2 diabetes treated with metformin
no metformin use
Patients with type 2 diabetes who are not being treated with metformin

Primary Outcome Measures :
  1. Vitamin B12 level [ Time Frame: Single point ]

Secondary Outcome Measures :
  1. methylmalonic acid [ Time Frame: single point ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient and hospitalized patients with type 2 diabetes mellitus

Inclusion Criteria:Age 20-80; diagnosed with type 2 diabetes for at least 30 days

Exclusion Criteria:known vitamin B12 or folate deficiency; pernicious anemia; on vitamin B12 therapy; hematological malignancy; methotrexate use; alcohol intake greater than two drinks per day; vegetarian diet; previous gastric surgery; inflammatory bowel disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01136512

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United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
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Principal Investigator: Neil Cohen, M.D. Staten Island University Hospital
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Responsible Party: Northwell Health Identifier: NCT01136512    
Other Study ID Numbers: 07040
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013
Keywords provided by Northwell Health:
vitamin B12
type 2 diabetes
methylmalonic acid
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Vitamin B 12 Deficiency
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin B Deficiency
Deficiency Diseases
Nutrition Disorders