The Effect of Vitamin K Supplementation on Glucose Metabo... | NCT00960973

Studies
The Effect of Vitamin K Supplementation on Glucose Metabolism

NCT00960973

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Aug 10, 2011Estimated

Enrollment

42Actual

Phase

Phase 4

Conditions

Diabetes
Prediabetic State

Interventions

Menatetrenone
Placebo

Countries

South Korea

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

Aug 2011

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

Sep 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 16, 2009

First Submission Date that Met QC Criteria

Aug 17, 2009

First Posted Date

Aug 18, 2009Estimated

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

Aug 9, 2011

Last Update Posted Date

Aug 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to test whether vitamin K supplementation has an effect on glucose metabolism in terms of acute beta cell response.

Detailed Description

Recently, many studies have reported that vitamin K metabolism is related to glucose metabolism. The suggested mechanisms connecting vitamin K metabolism and glucose metabolism, are inflammation responses and osteocalcin effect on glucose metabolism. Most of the studies have investigated fasting glucose and insulin sensitive index, few have assessed glucose-intake-stimulated responses in regard to vitamin K supplementation. The purpose of this study is to test whether vitamin K supplementation has an effect on glucose metabolism in terms of acute beta cell response using intravenous glucose tolerance test.

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin K	Experimental	Vitamin K supplementation (menatetrenone 30 mg, 3 times a day for 4 weeks)	Drug: Menatetrenone
Placebo control	Placebo Comparator	Placebo control	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Menatetrenone	Drug	Menatetrenone 30 mg, 3 times a day for 4 weeks	Vitamin K

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test)		4 weeks later

Secondary Outcomes

Measure	Description	Time Frame
beta-cell function (FSIGT)		4 weeks later
disposition index (FSIGT)		4 weeks later
insulin sensitivity (FSIGT)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male volunteer older than 20 years

Exclusion Criteria:

Subjects with (a history of) diabetes
Subjects receiving medication related to diabetes or obesity
Subjects receiving warfarin

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chan Soo Shin, MD, PhD	Seoul National University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Medical School		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D011236	Prediabetic State
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C030814	menatetrenone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided