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Clinical Trials/EUCTR2009-009155-37-FR
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

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.

Registry
who.int
Start Date
April 30, 2010
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
CHU-HOPITAUX DE ROUE

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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