Metformin Use and Vitamin B12 Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01136512
First received: June 2, 2010
Last updated: July 29, 2013
Last verified: July 2013
  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:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Vitamin B12 level [ Time Frame: Single point ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • methylmalonic acid [ Time Frame: single point ] [ 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
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
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Neil Cohen, M.D. Staten Island University Hospital
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01136512     History of Changes
Other Study ID Numbers: 07040
Study First Received: June 2, 2010
Last Updated: July 29, 2013
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 April 17, 2014