Metformin Use and Vitamin B12 Deficiency | NCT01136512

Studies
Metformin Use and Vitamin B12 Deficiency

NCT01136512

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Jul 31, 2013Estimated

Enrollment

89Actual

Phase

Not provided

Conditions

Vitamin B12 Deficiency
Type 2 Diabetes Mellitus

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jun 2, 2010

First Submission Date that Met QC Criteria

Jun 2, 2010

First Posted Date

Jun 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2013

Last Update Posted Date

Jul 31, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Measure	Description	Time Frame
Vitamin B12 level		Single point

Measure	Description	Time Frame
methylmalonic acid		single point

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Outpatient and hospitalized patients with type 2 diabetes mellitus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil Cohen, M.D.	Staten Island University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Staten Island University Hospital		Staten Island	New York	10305	United States

Condition Browse Module

MeSH Terms

ID	Term
D014806	Vitamin B 12 Deficiency
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D014804	Vitamin B Deficiency
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition

Browse Leaves

Not provided

Browse Branches

Not provided