NL-OMON56635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 trial - PYRAMID trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
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
- •- Age >= 18 years,
- •- Diagnosis of type 2 diabetes,
- •- Generalized microvascular dysfunction, i.e.
- •o eGFR 30-60 mL/min/1.73m2, and/or
- •o Microalbuminuria albumin/creatinine ratio 3-30 mg/mmol, and/or
- •o Retinopathy (not proliferative), and/or
- •o Neuropathy (any).
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Uncontrolled diabetes (i.e., hypoglycaemia >2 times/week and/or unstable
- •HbA1c >9%),
- •- Use of >12 Units long-acting insulin per day,
- •- Use of short-acting insulin,
- •- Intraocular pressure >=30 mmHg,
- •- History of glaucoma,
- •- Diagnosis of proliferative diabetic retinopathy,
- •- Diagnosis of diabetic macula edema,
- •- Albumine-creatinine ratio >30 mg/mmol,
- •- eGFR <30 mL/min/1.73m2,
- •- Diagnosis of epilepsy,
- •- Active cardiovascular disease (e.g. stroke, coronary artery disease,
- •congestive heart failure, cardiac shunts, history of cardiac surgery, pulmonary
- •hypertension, cardiac arrhythmias, family history of ventricular arrhythmias or
- •sudden cardiac death),
- •- Alcohol usage >4 U/day,
- •- Drugs abuse,
- •- Use of systemic glucocorticosteroids,
- •- Higher grade hypertension (> 179 mmHg SBP and/or > 109 mmHg DBP),
- •- Diagnosis of inflammatory disease,
- •- Use of an investigational product within the previous month,
- •- Unstable body weight (no drastic changes in lifestyle before or during the
- •intervention are allowed, this means no weight gain or loss >3 kg in the last
- •two months),
- •- Pregnancy or lactation,
- •- Change in use of oral contraceptives 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 to end of study,
- •- Insufficient knowledge of the Dutch language,
- •- Inability to provide written informed consent.
研究者
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