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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

Tracking Information
First Submitted Date  ICMJE August 16, 2009
First Posted Date  ICMJE August 18, 2009
Last Update Posted Date August 10, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2009)
AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test) [ Time Frame: 4 weeks later ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2009)
  • beta-cell function (FSIGT) [ Time Frame: 4 weeks later ]
  • disposition index (FSIGT) [ Time Frame: 4 weeks later ]
  • insulin sensitivity (FSIGT) [ Time Frame: 4 weeks later ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Vitamin K Supplementation on Glucose Metabolism
Official Title  ICMJE The Effect of Vitamin K Supplementation on Glucose Metabolism
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Prediabetic State
Intervention  ICMJE
  • Drug: Menatetrenone
    Menatetrenone 30 mg, 3 times a day for 4 weeks
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Vitamin K
    Vitamin K supplementation (menatetrenone 30 mg, 3 times a day for 4 weeks)
    Intervention: Drug: Menatetrenone
  • Placebo Comparator: Placebo control
    Placebo control
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2010)
42
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2009)
22
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00960973
Other Study ID Numbers  ICMJE Vitamin K
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chan Soo, Shin, Seoul National University Medical School
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chan Soo Shin, MD, PhD Seoul National University Medical School
PRS Account Seoul National University Hospital
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP