DiabetesPhase 4NCT00960973
The Effect of Vitamin K Supplementation on Glucose Metabolism
A Phase 4 study testing Menatetrenone in people with Diabetes and Prediabetic State, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Prediabetic State
- What is being tested?
- Menatetrenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteer older than 20 years
Who cannot join
- Subjects with (a history of) diabetes
- Subjects receiving medication related to diabetes or obesity
- Subjects receiving warfarin
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes, Prediabetic State
- Being tested
- Menatetrenone, Placebo
- Keywords
- vitamin K, beta cell, glucose metabolism, insulin resistance
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenatetrenoneDrug
Menatetrenone 30 mg, 3 times a day for 4 weeks
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K | Experimental | Vitamin K supplementation (menatetrenone 30 mg, 3 times a day for 4 weeks) Receives: Drug: Menatetrenone |
| Placebo control | Placebo comparator | Placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test)
Measured: 4 weeks later
Secondary outcomes (3)
beta-cell function (FSIGT)
Measured: 4 weeks later
disposition index (FSIGT)
Measured: 4 weeks later
insulin sensitivity (FSIGT)
Measured: 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chan Soo Shin, MD, PhD, Principal investigator, Seoul National University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960973
- Sponsor's protocol ID
- Vitamin K
- Status last verified
- Aug 2011
- First submitted
- 16 Aug 2009
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin K Supplementation on Glucose Metabolism
- ClinicalTrials.gov ID
- NCT00960973
- Acronym / sponsor ID
- Vitamin K
- Conditions
- Diabetes, Prediabetic State
- Keywords
- vitamin K, beta cell, glucose metabolism, insulin resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin K | Experimental | Drug: MenatetrenoneVitamin K supplementation (menatetrenone 30 mg, 3 times a day for 4 weeks) |
| Placebo control | Placebo comparator | Drug: PlaceboPlacebo control |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male volunteer older than 20 years
Key exclusion criteria (3 listed)
- Subjects with (a history of) diabetes
- Subjects receiving medication related to diabetes or obesity
- Subjects receiving warfarin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenatetrenoneMenatetrenone 30 mg, 3 times a day for 4 weeks | Drug | Vitamin K |
| PlaceboPlacebo | Drug | Placebo control |
Primary outcome
AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test)
Time frame: 4 weeks later
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chan Soo Shin, MD, PhD principal investigator
Seoul National University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Menatetrenone in people with Diabetes and Prediabetic State, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test) (time frame: 4 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011.