The Effect of Vitamin K Supplementation on Glucose Metabolism

Diabetes Clinical Trial

Official title:

The Effect of Vitamin K Supplementation on Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960973
• Other study ID #: Vitamin K
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2009
• Last updated: August 9, 2011
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Prediabetic State

Intervention

Drug:
• Menatetrenone
Menatetrenone 30 mg, 3 times a day for 4 weeks
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Medical School	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test)		4 weeks later	No
Secondary	beta-cell function (FSIGT)		4 weeks later	No
Secondary	disposition index (FSIGT)		4 weeks later	No
Secondary	insulin sensitivity (FSIGT)		4 weeks later	No