Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes (Vita-K 'n' Adults Study)
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|ClinicalTrials.gov Identifier: NCT02366481|
Recruitment Status : Recruiting
First Posted : February 19, 2015
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Insulin Resistance Insulin Sensitivity Beta-Cell Dysfunction Prediabetes||Dietary Supplement: Placebo Dietary Supplement: Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d) Dietary Supplement: High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Placebo Comparator: Placebo-Control
The placebo-control group will take two placebo softgel capsules every day for 8 weeks.
Dietary Supplement: Placebo
Two placebo softgel capsules (containing no vitamin K2) every day for 8 weeks.
Active Comparator: Low-Dose Vitamin K2 (90-mcg/d)
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.
Dietary Supplement: Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d)
One 90-mcg vitamin K2 softgel capsules (containing no vitamin K2) and one placebo softgel capsule everyday for 8 weeks.
Active Comparator: High-Dose Vitamin K2 (180-mcg/d)
The high-dose vitamin K group will take two 90-mcg vitamin K2 (menaquinone-7) softgel capsules every day for 8 weeks.
Dietary Supplement: High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)
Two 90-mcg vitamin K2 softgel capsules every day for 8 weeks.
- Change in insulin sensitivity [ Time Frame: Change from baseline in insulin sensitivity at 8 weeks ]Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a 2-hour oral glucose tolerance test by using the oral glucose minimal model.
- Change in beta-cell function [ Time Frame: Change from baseline in beta-cell function at 8 weeks ]Beta-cell function, as assessed by dynamic beta-cell responsitivity, will be calculated from plasma glucose and C-peptide concentrations measured during a 2-hour oral glucose tolerance test by using the oral C-peptide minimal model.
- Change in prothrombin time (PT) [ Time Frame: Change from baseline in PT at 8 weeks ]
- Change in activated partial thromboplastin time (aPTT) [ Time Frame: Change from baseline in aPTT at 8 weeks ]
- Change in arterial stiffness (PWV) [ Time Frame: Change from baseline in arterial stiffness at 8 weeks ]Arterial stiffness will be assessed using carotid-femoral pulse wave velocity (PWV) by applanation tonometry.
- Change in endothelial function (FMD) [ Time Frame: Change from baseline in endothelial function at 8 weeks ]Endothelial function will be assessed using brachial artery flow-mediated dilation (FMD) by ultrasound.
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): NCT02366481
|Contact: Norman K Pollock, Ph.D.||firstname.lastname@example.org|
|Contact: Celestine F Williams, M.S.||email@example.com|
|United States, Georgia|
|Medical College of Georgia; Augusta University||Recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Norman K Pollock, Ph.D. 706-721-5424 firstname.lastname@example.org|
|Principal Investigator:||Norman K Pollock, Ph.D.||Department of Pediatrics, Medical College of Georgia, Augusta University|