EUCTR2017-003124-73-NL进行中(未招募)1 期
Carnitine supplementation as a therapy to improve insulin sensitivity in Type 2 diabetic patients with low carnitine status - Carnitine supplementation and insulin sensitivity
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men and woman
- •Age: 40-70 years
- •Woman should be postmenopausal
- •BMI: 25-35 kg/m2
- •Stable dietary habits
- •No use of medication interfering with investigated study parameters (as determined by responsible physician)
- •Use of oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •Haemoglobin levels < 7.8 mmol/L •Uncontrolled hypertension •Use of anticoagulants •Insulin dependent type 2 diabetic patients. •No signs of active liver or kidney malfunction. •Engagement in exercise > 3 hours a week •Being vegetarian or vegan (because of altered whole body carnitine status) •Alcohol and/or drug abuse •Unstable body weight (weight gain or loss > 5kg in the last 3 months) •Significant food allergies/intolerances (seriously hampering study meals) •Participation in another biomedical study within 1 month before the first study visit, which would possibly hamper our study results •Medication use known to hamper subject's safety during the study procedures •Subjects with contra-indications for MRI •Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the study •Subjects who do not want to be informed about unexpected medical findings •No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
研究者
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