Obese patients suffering of metabolic syndrome
Conditions
Interventions
Trade Name: Arginine Veyron
Pharmaceutical Form: Oral powder
Sponsors
CHU-HOPITAUX DE ROUEN
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To ameliorate body composition (% of body fat mass, % of body lean mass, bone mineral density), resting energy expenditure, insulin resistance, metabolic syndrome parameters, cardiac variability, quadriceps force and quality of life score (SF-36 auto-questionnaire) in obese patients suffering of metabolic syndrome.;Secondary Objective: To ameliorate body composition (% of body fat mass, % of body lean mass, bone mineral density), resting energy expenditure, insulin resistance, metabolic syndrome parameters, cardiac variability, quadriceps force and quality of life score (SF-36 auto-questionnaire) in obese patients suffering of metabolic syndrome.;Primary end point(s): Variation of total fat mass estimated by DEXA | — |
Countries
France
Outcome results
None listed