NL-OMON50192招募中不适用
The effect of pyridoxamine supplementation on vascular function and insulin sensitivity; a double-blind randomized placebo controlled trial in abdominally obese subjects. - Pyridoxamine supplementation, vascular function and insulin sensitivity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Abdominal obesity: Waist circumference for men should be above 102 cm, for
- •women above 88 cm.
- •- Caucasian (because of skin fluorescence and capillary microscopy measurements)
- •- Aged 18-75 years
排除标准
- •- Diabetes mellitus (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
- •- Smoking will be allowed. Smokers will be excluded only if they smoke >10
- •cigarettes per day.
- •- High alcohol usage (>4 U/day) or drug abuse
- •- Use of medication known to influence glucose metabolism or vascular function
- •(e.g. glucocorticosteroids, NSAID's)
- •- Exclusion of higher grade hypertension (> 179 mmHg SBP and/or > 109 mmHg DBP)
- •in order not to expose subjects to unnecessary risks. Medication is allowed.
- •- 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
- •- 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
研究者
相似试验
招募中
不适用
The effect of pyridoxamine supplementation on microvascular function in type 2 diabetes: a double-blind randomized placebo-controlled cross-over trialNL-OMON56635niversiteit Maastricht40
已完成
不适用
Effect of Pyridoxamine Supplementation on Vascular Function and Insulin SensitivityAbdominal Obesity Metabolic SyndromeNCT02954588Maastricht University Medical Center112
招募中
2 期
Pyridoxamine for menopausal disordermenopausal disorder with psychological symptomsJPRN-jRCTs031220256Terauchi Masakazu50
已完成
不适用
The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 DiabetesMicrovascular FunctionType 2 DiabetesRetinopathy, DiabeticNephropathy, DiabeticNeuropathy, DiabeticNCT06376240Maastricht University Medical Center40
已完成
不适用
Evaluation of effect of pyridoxamine on reducing carbonyl stress in patients receiving peritoneal dialysis. -Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysisPeritoneal dialysis patientsJPRN-UMIN000020956Fukushima Medical University6