EUCTR2009-009155-37-FR进行中（未招募）1 期
Evaluation of the impact of physical reconditioning associated with specific nutritional supplementation in obese patients suffering of metabolic syndrome. - OBEFITT
CHU-HOPITAUX DE ROUE0 个研究点目标入组 80 人开始时间: 2010年4月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
入选标准
- •Suffering of obesity (BMI> 30 kg.m-2) with a maximal weight of 135 kg
- •Suffering of metabolic syndrome (NCEP definition)
- •Hospitalized or followed in consultation
- •Aged of 18 to 45 year old
- •Not having participated to other clinical studies during the last 30 days before pre-inclusion consultation
- •Affiliated to a national insurance scheme
- •Having a social insurance
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Asthma, chronic respiratory failure, obstructive chronic bronchitis
- •Current or recent Pneumothorax, recent pleural draining or biopsy, current hemoptysia, untreated / in course of treatment active tuberculosis
- •Coronaropathy, myocardiopathy, myocarditis, unstable cardiac failure, ventricular rythm disorders
- •Severe Anaemia
- •Severe inferior members Arteritis
- •Incapacity of walking or pedaling
- •Severe renal failure (Creatinine Clearance < ou = 30 mL/min)
- •Severe Sepsis
- •Psychiatric Troubles (DSM IV criteria) such as schizophrenia, others psychoses or major depressive non treated syndromes
- •Severe or non treated eating disorders implicated in obesity (compulsive access, bulimia)
- •Patients under guardianship or under guardianship
- •Women in age of procreation without means of effective contraception
- •Pregnant or breast-feeding women
- •Taking of medicines such as : proteinated powder (Protifar®, SP95®), Orlistat (Xenical®, Alli®), Exenatide (Byetta®), Sitagliptine (Januvia®, Xelevia®), Vildapgliptine (Galvus®), association Sitagliptine-Metformine (Janumet®), association Vildagliptine-Metformine (Eucreas®), Tadalafil (Cialis®), Sildénafil (Viagra®)
- •Drug addiction to opiates in the last six months
- •Abuse of alcohol and other toxic matters
- •Infection by HIV, viral hepatitis B and viral hepatitis C
- •Active addiction to smoking in more than 8 cigarettes a day
- •Understanding badly spoken or written French
- •Realization, in 2 in 3 days preceding the DEXA exam, of a bone scintigraphy or a digestive tract's radiological examination with product of contrast of type baryte.
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