Metformin Use and Vitamin B12 Deficiency

NCT ID: NCT01136512

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin B12 Deficiency Type 2 Diabetes Mellitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

metformin vitamin B12 type 2 diabetes methylmalonic acid deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

metformin use

Patients with type 2 diabetes treated with metformin

No interventions assigned to this group

no metformin use

Patients with type 2 diabetes who are not being treated with metformin

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Neil Cohen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Staten Island University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Staten Island University Hospital

Staten Island, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07040

Identifier Type: -

Identifier Source: org_study_id