NCT00960973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 10, 2011

Status Verified

August 1, 2011

Enrollment Period

1.2 years

First QC Date

August 16, 2009

Last Update Submit

August 9, 2011

Conditions

DiabetesPrediabetic State

Keywords

vitamin Kbeta cellglucose metabolisminsulin resistance

Outcome Measures

Primary Outcomes (1)

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

    4 weeks later

Secondary Outcomes (3)

  • beta-cell function (FSIGT)

    4 weeks later

  • disposition index (FSIGT)

    4 weeks later

  • insulin sensitivity (FSIGT)

    4 weeks later

Study Arms (2)

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

MenatetrenoneDRUG

Menatetrenone 30 mg, 3 times a day for 4 weeks

Vitamin K
PlaceboDRUG

Placebo

Placebo control

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male volunteer older than 20 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Medical School

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes MellitusPrediabetic StateInsulin Resistance

Interventions

menatetrenone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Chan Soo Shin, MD, PhD

    Seoul National University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2009

First Posted

August 18, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 10, 2011

Record last verified: 2011-08

Locations

KR(1)