NCT01136512

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

June 2, 2010

Last Update Submit

July 29, 2013

Conditions

Vitamin B12 DeficiencyType 2 Diabetes Mellitus

Keywords

metforminvitamin B12type 2 diabetesmethylmalonic aciddeficiency

Outcome Measures

Primary Outcomes (1)

  • Vitamin B12 level

    Single point

Secondary Outcomes (1)

  • methylmalonic acid

    single point

Study Arms (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 Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient and hospitalized patients with type 2 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Vitamin B 12 DeficiencyDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Neil Cohen, M.D.

    Staten Island University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

August 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

US(1)