The Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity; a Double-blind Randomized Placebo Controlled Trial in Abdominally Obese Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Insulin sensitivity
研究概览
简要总结
A growing body of evidence demonstrates that increased adipose mass, especially visceral adipose tissue, contributes directly towards an increase in systemic inflammation, (micro-)vascular dysfunction and the burden of cardiovascular disease (CVD), insulin resistance and type 2 diabetes. Advanced glycation/lipoxidation endproducts (AGEs/ALEs) are a heterogeneous family of unavoidable by-products, which are formed by reactive metabolic intermediates derived from glucose and lipid oxidation. In addition to the overwhelming amount of data demonstrating the role of AGEs/ALEs in the development of (micro-)vascular dysfunction and disease, accumulation of AGEs/ALEs in the expanding adipose tissue contributes to the dysregulation of adipokines and the development of insulin resistance.
The investigators want to examine, in a double-blind randomized placebo controlled parallel study, the physiological effect of a dietary intervention with pyridoxamine in abdominally obese persons.
A sub-study is implemented next to the clinical trial. The objective of the sub-study is to measure the metabolization and kinetics of pyridoxamine in plasma and urine with UPLC-MS/MS. The sub-study comprises of 5 additional healthy volunteers, with pyridoxamine as an oral supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Abdominal obesity: Waist circumference for men should be above 102 cm and for women above 88 cm.
- •Caucasian (because of skin fluorescence and capillary microscopy measurements)
- •Aged 18-75 years
排除标准
- •Diabetes (i.e. using anti-diabetic medication, fasting glucose >7.0 mmol/L, HbA1c >6.5%).
- •Active or history of cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
- •Hyperlipidemia (defined as serum total cholesterol > 8 mmol/L or TG > 4 mmol/L)
- •Smoking (>10 cigarettes per day)
- •High alcohol usage (>4 U/day) or drug abuse
- •Use of medication known to influence glucose metabolism, vascular function (e.g. glucocorticosteroids, NSAID's)
- •Higher grade hypertension (> 179 mmHg SBP and/or > 109 mmHg DBP) in order not to expose subjects to unnecessary risks)
- •Known allergic reaction to ultrasound contrast-agent
- •Pulmonary or inflammatory disease
- •Kidney failure or electrolyte disorders
- •Use of dietary supplements or an investigational product within the previous month
- •Unstable body weight (no drastic changes in life style before or during the intervention are allowed, this means no weight gain or loss >3 kg in the last two months)
- •Pregnancy or lactation
- •No change in use of oral anticonceptiva or IUD (12 weeks prior of during the intervention)
- •Unwillingness to give up being a blood donor (or having donated blood) from 8 weeks prior to the start of the study and during the study
- •Insufficient knowledge of the Dutch language
研究组 & 干预措施
Placebo
Subjects will be asked to consume dietary supplements containing placebo (amylum solani), three times daily during 8 weeks
干预措施: Placebo (Dietary Supplement)
Pyridoxamine (2)
Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 2), three times daily during 8 weeks
干预措施: Pyridoxamine (Dietary Supplement)
Pyridoxamine (1)
Subjects will be asked to consume dietary supplements containing pyridoxamine (dosage 1), three times daily during 8 weeks.
干预措施: Pyridoxamine (Dietary Supplement)
结局指标
主要结局
Insulin sensitivity
时间窗: Difference after 8 weeks of intervention
Assessed by hyperinsulinemic-euglycemic clamp
Microvascular function
时间窗: Difference after 8 weeks of intervention
Assessed by contrast-enhanced ultrasound (CEUS) in skeletal muscle
次要结局
未报告次要终点