Metformin Use and Vitamin B12 Deficiency
This study has been completed.
Sponsor:
Staten Island University Hospital
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01136512
First received: June 2, 2010
Last updated: NA
Last verified: February 2009
History: No changes posted
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Purpose
The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.
| Condition |
|---|
|
Vitamin B12 Deficiency Type 2 Diabetes Mellitus |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Metformin Use and Vitamin B12 Deficiency |
Resource links provided by NLM:
Drug Information available for:
Cyanocobalamin
Metformin
Metformin hydrochloride
Vitamin B Complex
Hydroxocobalamin
U.S. FDA Resources
Further study details as provided by North Shore Long Island Jewish Health System:
Primary Outcome Measures:
- Vitamin B12 level [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- methylmalonic acid [ Designated as safety issue: No ]
| Enrollment: | 89 |
| Study Start Date: | August 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| 1 |
| 2 |
|
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
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Outpatient and hospitalized patients with type 2 diabetes mellitus
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136512
Locations
| United States, New York | |
| Staten Island University Hospital | |
| Staten Island, New York, United States, 10305 | |
Sponsors and Collaborators
Staten Island University Hospital
Investigators
| Principal Investigator: | Neil Cohen, M.D. | Staten Island University Hospital |
More Information
No publications provided
| Responsible Party: | Neil Cohen M.D., Staten Island University Hospital |
| ClinicalTrials.gov Identifier: | NCT01136512 History of Changes |
| Other Study ID Numbers: | 07040 |
| Study First Received: | June 2, 2010 |
| Last Updated: | June 2, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by North Shore Long Island Jewish Health System:
|
metformin vitamin B12 type 2 diabetes methylmalonic acid deficiency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Vitamin B 12 Deficiency Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vitamin B Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin B 12 |
Hydroxocobalamin Vitamin B Complex Vitamins Metformin Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 23, 2013