NL-OMON48992已完成不适用
Restriction of dietary AGEs to prevent diabetes in overweight individuals: a randomized controlled trial - de-AGE-ing study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
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 * 102 cm, and for women * 88 cm.
- •- Caucasian
- •- Aged 18 years and older
- •- BMI * 25 kg/m2
排除标准
- •- Diabetes (i.e. using anti-diabetic medication, fasting glucose >7.0 mmol/L, HbAc1 > 6.5%).
- •- Active of 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).
- •- Hyperlipidaemia (defined as serum total cholesterol > 8 mmol/L or TG > 4 mmol/L).
- •- Lipid lowering medication (e.g. statins).
- •- Use of medication known to influence glucose metabolism, vascular function, and/or lipid metabolism (e.g. statins, glucocorticosteroids, NSAID*s).
- •- Inability to stop anti-hypertensive medication for 8 weeks. Exclusion of higher grade hypertension (> 179 mmHG SBP and/or > 109 mmHg DBP) in order not to expose subjects to unnecessary risks).
- •- Pulmonary or inflammatory disease
- •- Kidney failure or electrolyte disorder
- •- Pregnancy or lactation
- •- No change in use of oral anticonceptives or IUD (12 weeks before the intervention).
- •- Unstable body weight (weight gain or loss > 3 kg in the last 2 months).
- •- Known allergic reaction to ultrasound contrast-agent
- •- Smoking (active or cessation <1 year prior to screening date).
- •- High alcohol usage (>4 U/day) or drug abuse
- •- Use of dietary supplements or an investigation product within the previous month
- •- Significant food allergies/intolerance
- •- Vegetarianism
- •- Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
- •- Participation in another biomedical trial during the past 30 days.
研究者
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