The Effect of Vitamin K Supplementation on Glucose Metabolism

NCT ID: NCT00960973

Last Updated: 2011-08-10

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Prediabetic State

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vitamin K

Vitamin K supplementation (menatetrenone 30 mg, 3 times a day for 4 weeks)

Group Type EXPERIMENTAL

Menatetrenone

Intervention Type DRUG

Menatetrenone 30 mg, 3 times a day for 4 weeks

Placebo control

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Menatetrenone

Menatetrenone 30 mg, 3 times a day for 4 weeks

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Medical School

Principal Investigators

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Chan Soo Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Medical School

Locations

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Seoul National University Medical School

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Vitamin K

Identifier Type: -

Identifier Source: org_study_id

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