Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in insulin sensitivity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between 18 and 65 years old
- •Subject understands the study protocol and agrees to comply with it
- •Informed Consent Form signed by the subject
排除标准
- •Subjects using vitamin supplements containing vitamin k
- •Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
- •Subjects presenting chronic degenerative and/or inflammatory diseases
- •Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
- •Subjects receiving corticosteroid treatment
- •Subjects using oral anticoagulants
- •Subjects with a history of soy allergy
- •Subjects who have participated in a clinical study more recently than one month before the current study
结局指标
主要结局
Change in insulin sensitivity
时间窗: 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
时间窗: 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.
次要结局
- Change in arterial stiffness (PWV)(Change from baseline in arterial stiffness at 8 weeks)
- Change in prothrombin time (PT)(Change from baseline in PT at 8 weeks)
- Change in activated partial thromboplastin time (aPTT)(Change from baseline in aPTT at 8 weeks)
- Change in endothelial function (FMD)(Change from baseline in endothelial function at 8 weeks)
研究者
Norman Pollock
Associate Professor, Department of Medicine
Augusta University