- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01136512
Metformin Use and Vitamin B12 Deficiency
July 29, 2013 updated by: Northwell Health
The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
89
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Staten Island, New York, United States, 10305
- Staten Island University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Outpatient and hospitalized patients with type 2 diabetes mellitus
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vitamin B12 level
Time Frame: Single point
|
Single point
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
methylmalonic acid
Time Frame: single point
|
single point
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Cohen, M.D., Staten Island University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
June 2, 2010
First Submitted That Met QC Criteria
June 2, 2010
First Posted (Estimate)
June 3, 2010
Study Record Updates
Last Update Posted (Estimate)
July 31, 2013
Last Update Submitted That Met QC Criteria
July 29, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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