Vitamin K and Glucose Metabolism in Children 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 serum lipid concentrations
研究概览
简要总结
The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models). Clinical trials are needed to isolate the effects of vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk. The purpose of this pilot randomized, double-blind, placebo-controlled trial in children is to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to improve carboxylation of both osteocalcin and matrix Gla protein), and whether it can have an effect on markers associated with diabetes and cardiovascular disease 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
- 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
- •BMI less than 85th percentile for age and gender
- •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 serum lipid concentrations
时间窗: 8 weeks
To determine if vitamin K supplementation improves fasting lipid panel (triglycerides, total cholesterol, HDL-cholesterol, and LDL-cholesterol) in a dose-dependent manner.
Change in insulin sensitivity
时间窗: 8 weeks
To determine if vitamin K supplementation improves insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a 2-hour glucose tolerance test by using the oral glucose minimal model.
Change in beta-cell function
时间窗: 8 weeks
To determine if vitamin K supplementation improves insulin sensitivity 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 2-hour glucose tolerance test by using the oral C-peptide minimal model.
次要结局
- Change in coagulation(8 weeks)
- Change in arterial stiffness (pulse wave velocity)(8 weeks)
- Change in endothelial function (Flow-mediated dilation)(8 weeks)
- Effects of sex, race, bone age, and pubertal stage on changes in glucosemetabolism (insulin sensitivity and beta-cell function)(8 weeks)
研究者
Norman Pollock
Associate Professor, Department of Medicine
Augusta University