The Effect of Vitamin K Supplementation on Glucose Metabolism

August 9, 2011 updated by: Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control
Drug: Placebo
Placebo
Experimental: Vitamin K
Vitamin K supplementation (menatetrenone 30 mg, 3 times a day for 4 weeks)
Drug: Menatetrenone
Menatetrenone 30 mg, 3 times a day for 4 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Chan Soo Shin, MD, PhD, Seoul National University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 16, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

August 10, 2011

Last Update Submitted That Met QC Criteria

August 9, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin K

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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