E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obese patients suffering of metabolic syndrome |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Variation of total fat mass estimated by DEXA |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
control group without nutritional supplementation |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last patient inclusion date |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 45 |
E.8.9.1 | In the Member State concerned days | 0 |