EUCTR2009-009155-37-FR
Active, not recruiting
Phase 1
Evaluation of the impact of physical reconditioning associated with specific nutritional supplementation in obese patients suffering of metabolic syndrome. - OBEFITT
CHU-HOPITAUX DE ROUE0 sites80 target enrollmentApril 30, 2010
DrugsArginine Veyron
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHU-HOPITAUX DE ROUE
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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