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The Effect of Vitamin K Supplementation on Glucose Metabolism

Primary Purpose

Diabetes, Prediabetic State

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Menatetrenone

Placebo

About this trial

This is an interventional treatment trial for Diabetes focused on measuring vitamin K, beta cell, glucose metabolism, insulin resistance

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Seoul National University Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin K

Placebo control

Arm Description

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

Placebo control

Outcomes

Primary Outcome Measures

AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test)

Secondary Outcome Measures

beta-cell function (FSIGT)

disposition index (FSIGT)

insulin sensitivity (FSIGT)

Full Information

NCT ID

NCT00960973

First Posted

August 16, 2009

Last Updated

August 9, 2011

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00960973

Brief Title

The Effect of Vitamin K Supplementation on Glucose Metabolism

Official Title

The Effect of Vitamin K Supplementation on Glucose Metabolism

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Prediabetic State

Keywords

vitamin K, beta cell, glucose metabolism, insulin resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin K

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo control

Arm Type

Placebo Comparator

Arm Description

Placebo control

Intervention Type

Drug

Intervention Name(s)

Menatetrenone

Intervention Description

Menatetrenone 30 mg, 3 times a day for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test)

Time Frame

4 weeks later

Secondary Outcome Measure Information:

Title

beta-cell function (FSIGT)

Time Frame

4 weeks later

Title

disposition index (FSIGT)

Time Frame

4 weeks later

Title

insulin sensitivity (FSIGT)

Time Frame

4 weeks later

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chan Soo Shin, MD, PhD

Organizational Affiliation

Seoul National University Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Medical School

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

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The Effect of Vitamin K Supplementation on Glucose Metabolism

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