Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk
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
Animal studies have found that vitamin K-dependent proteins matrix Gla protein and osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K supplementation presents an opportunity to test the hypothesized link between the vitamin K-dependent proteins and markers of lipid and glucose metabolism. The investigators will conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk. Sixty obese children will be randomly allocated to either the control group receiving placebo or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K (menaquinone-7).
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
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 8 to 17 years
- •Body mass index equal to or greater than 85th percentile for age and sex
- •Subject and parent/guardian understands the study protocol and agrees to comply with it
- •Informed Consent Form signed by the parent/guardian and assent 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: 8 weeks
To determine if the vitamin K-induced change in osteocalcin carboxylation effects insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a two-hour oral glucose tolerance test by using the oral glucose minimal model.
Change in serum lipid concentrations
时间窗: 8 weeks
To determine if the vitamin K-induced change in matrix Gla protein carboxylation improves fasting lipid panel (triglycerides, total cholesterol, HDL-cholesterol, and LDL-cholesterol) in a dose-dependent manner.
Change in beta-cell function
时间窗: 8-weeks
To determine if the vitamin K-induced change in osteocalcin carboxylation effects beta-cell function in a dose-dependent manner. Beta-cell function, as assessed by dynamic beta-cell responsitivity, will be calculated from plasma glucose and C-peptide concentrations measured during a two-hour oral glucose tolerance test by using the oral C-peptide minimal model.
次要结局
- Change in endothelial function (flow-mediated dilation)(8 weeks)
- Change in arterial stiffness (pulse wave velocity)(8 weeks)
- Change in coagulation(8 weeks)
研究者
Norman Pollock
Associate Professor
Augusta University