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The Effect of Vitamin K Supplementation on Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT00960973
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Prediabetic State Drug: Menatetrenone Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin K Supplementation on Glucose Metabolism
Study Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Menadione

Arm Intervention/treatment
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

Placebo Comparator: Placebo control
Placebo control
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test) [ Time Frame: 4 weeks later ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960973


Locations
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Korea, Republic of
Seoul National University Medical School
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Chan Soo Shin, MD, PhD Seoul National University Medical School

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Responsible Party: Chan Soo, Shin, Seoul National University Medical School
ClinicalTrials.gov Identifier: NCT00960973     History of Changes
Other Study ID Numbers: Vitamin K
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: August 2011

Keywords provided by Seoul National University Hospital:
vitamin K
beta cell
glucose metabolism
insulin resistance

Additional relevant MeSH terms:
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Diabetes Mellitus
Vitamins
Vitamin K
Vitamin K 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Menatetrenone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants