Evaluation of the impact of physical reconditioning associated with specific nutritional supplementation in obese patients suffering of metabolic syndrome. - OBEFITT
- Conditions
- Obese patients suffering of metabolic syndrome
- Registration Number
- EUCTR2009-009155-37-FR
- Lead Sponsor
- CHU-HOPITAUX DE ROUE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method