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Completed

NCT Number: NCT00960973

The Effect of Vitamin K Supplementation on Glucose Metabolism

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Medical School

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menatetrenone

Drug

Menatetrenone 30 mg, 3 times a day for 4 weeks

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: 4 weeks later

Secondary outcomes

  1. beta-cell function (FSIGT)

    Time frame: 4 weeks later

  2. disposition index (FSIGT)

    Time frame: 4 weeks later

  3. insulin sensitivity (FSIGT)

    Time frame: 4 weeks later

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 18, 2009
Registry last updated
Aug 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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