NCT03531879已完成不适用
ARROW: identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2018年5月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- To compare the kinetics of postprandial biomarkers between two groups of healthy subjects with and without subclinical atherosclerosis
研究概览
简要总结
The purpose of this study is to better understand the association between the postprandial biomarker responses after a food challenge with the development of cardiovascular diseases in healthy subjects
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to sign written informed consent in English or Chinese prior to trial entry
- •40-54 years old
- •Both male and female subjects
- •Chinese ethnic group (having both grandparents Chinese)
- •Low Framingham risk of CHD (<10%)
- •Apparently healthy (i.e. no chronic or ongoing acute disease), based on investigator's clinical judgement
排除标准
- •Food allergy to any of the constituents of the meal challenge (milk proteins, lactose, soy).
- •Subjects not willing or not able to comply with scheduled visits and the requirements of the study protocol.
- •Contraindication to MRI
- •Pregnant or lactating women based on investigator's clinical judgement.
- •Morbid obesity (BMI ≥ 40 kg/m2).
- •Previous myocardial infarction (MI). This will include ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI).
- •Known coronary artery disease - prior coronary revascularization.
- •Known documented peripheral arterial disease.
- •Previous stroke (defined as new focal neurological deficit persisting more than 24hours).
- •Use of anti-hypertensive agents.
- •Prior history of cancer (excludes pre-cancerous lesions).
- •Life expectancy less than 1 year.
- •Known definite diabetes mellitus or on treatment for diabetes mellitus.
- •Known autoimmune disease or genetic disease.
- •Known endocrine and metabolic diseases, even on treatment, including hyperlipidemia.
- •Psychiatric illness.
- •Asthma or chronic lung disease requiring long term medications or oxygen.
- •Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV.
- •Currently participating or having participated in another clinical trial within 4 weeks prior to trial start (except for Biobank Study and SingHeart).
结局指标
主要结局
To compare the kinetics of postprandial biomarkers between two groups of healthy subjects with and without subclinical atherosclerosis
时间窗: Within 28 days from enrollment
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Study to Assess Selected Biomarkers in Subjects Requiring Daily Inhaled Corticosteroids for Persistent AsthmaAsthmaNCT01334853MedImmune LLC97
Unknown
不适用
Development of Biomarker for the Evaluation of Response After Neoadjuvant Therapy in Patients With Pancreatic CancerGenetic ChangeChemotherapy EffectPancreatic CancerNCT04110769Asan Medical Center10
招募中
不适用
Biomarkers in Retinitis PigmentosaRetinitis PigmentosaNCT06306690Fondazione Policlinico Universitario Agostino Gemelli IRCCS35
Unknown
不适用
Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)Respiratory Distress Syndrome, AdultNCT03236272Mingdong Hu376
已完成
不适用
Investigation of biomarkers for predicting the response to steroids in patients with COPDCOPDJPRN-UMIN000010711Third Department of Internal Medicine, Wakayama Medical University80