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Vitamin K2 Supplement
Low-Dose Vitamin K2 (90-mcg/d) for Insulin Resistance
N/A
Waitlist Available
Led By Norman K Pollock, Ph.D.
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject understands the study protocol and agrees to comply with it
Informed Consent Form signed by the subject
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in aptt at 8 weeks
Awards & highlights
Study Summary
Given that glutamate carboxylation or decarboxylation is key to the metabolic role of osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and its subsequent effect on glucose metabolism in clinical trials. The purpose of this randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in blood associated with diabetes risk.
Eligible Conditions
- Insulin Resistance
- Obesity
- Insulin Sensitivity
- Type 1 Diabetes
- Prediabetes
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline in beta-cell function at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in beta-cell function at 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in beta-cell function
Change in insulin sensitivity
Secondary outcome measures
Change in activated partial thromboplastin time (aPTT)
Change in arterial stiffness (PWV)
Body Weight Changes
+1 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Low-Dose Vitamin K2 (90-mcg/d)Active Control1 Intervention
The low-dose vitamin K group will take one 90-mcg vitamin K2 (menaquinone-7) softgel capsule and one placebo softgel capsule every day for 8 weeks.
Group II: High-Dose Vitamin K2 (180-mcg/d)Active Control1 Intervention
The high-dose vitamin K group will take two 90-mcg vitamin K2 (menaquinone-7) softgel capsules every day for 8 weeks.
Group III: Placebo-ControlPlacebo Group1 Intervention
The placebo-control group will take two placebo softgel capsules every day for 8 weeks.
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Who is running the clinical trial?
Yale UniversityOTHER
1,837 Previous Clinical Trials
2,728,383 Total Patients Enrolled
26 Trials studying Insulin Resistance
5,381 Patients Enrolled for Insulin Resistance
Tufts UniversityOTHER
260 Previous Clinical Trials
661,092 Total Patients Enrolled
5 Trials studying Insulin Resistance
290 Patients Enrolled for Insulin Resistance
Augusta UniversityLead Sponsor
210 Previous Clinical Trials
85,026 Total Patients Enrolled
2 Trials studying Insulin Resistance
60 Patients Enrolled for Insulin Resistance
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