Clinical trial NCT01326416: Evaluation of the Impact of Physical Reconditioning Associated With Specific Nutritional Supplementation in Obese Patients Suffering From Metabolic Syndrome
Official title: Evaluation of the Impact of Physical Reconditioning Associated With Specific Nutritional Supplementation in Obese Patients Suffering From Metabolic Syndrome. OBEFITT Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Keywords: obesity
metabolic syndrome
leucine
arginine
physical activity
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Android obesity contributes, via insulin resistance and endothelial dysfunction, to the development of cardiovascular atherosclerosis. It leads to poor quality of life. It is often associated with metabolic syndrome which includes, whatever the definitions used (National Education Cholesterol Program, NECP / Adult Treatment Panel III, ATP III or International Diabetes Federation, IDF), an increased waist measurement, an arterial high blood pressure and disorders of the glucide and lipid metabolism. The treatment of the current "epidemic" of obesity and metabolic syndrome in France (12.4 % of obese and 14 % of subjects with metabolic syndrome) thus requires new therapeutic approaches.

A well-balanced diet and a daily physical activity are the indispensable requirements for the treatment of obesity and metabolic syndrome. It is possible to associate it to pharmacological agents, but the results are often partial and transient. Preliminary data suggest that leucine or arginine supplementation could facilitate the loss of fat mass. Moreover, the physical exercise has also demonstrated benefits.

Sessions of physical reconditioning (aerobic work + muscular intensification) associated with a program of specific nutritional supplementation by a mixture of Leucine and Arginine (in the daytime) could improve the treatment of obese subjects affected by metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Suffering from obesity (Body Mass Index (BMI) \> 30kg.m-2) with a maximal weight of 135 kg
* Suffering from metabolic syndrome (International Federation of Diabetes(FID) definition)
* Hospitalized or followed in consultation
* Age 18 to 55 years old
* Not having recently participated in other clinical studies during the last days before pre-inclusion consultation
* Affiliated to a National Insurance scheme
* Having National Social Security insurance

Exclusion Criteria:

* Asthma, chronic respiratory failure, obstructive chronic bronchitis
* Current or recent Pneumothorax, recent pleural draining or biopsy, current hemoptysis, untreated / in course of treatment active tuberculosis
* Coronaropathy, myocardiopathy, myocarditis, unstable cardiac failure, ventricular rhythm disorders
* Severe Anemia
* Severe inferior members Arteritis
* Incapacity to walk or cycle
* Severe renal failure (Creatinine Clearance \<or = 30 mL/min)
* Severe Sepsis
* Psychiatric Disorders (Diagnostic and Statistical Manual - Revision 4 (DSM IV) criteria) such as schizophrenia, other psychoses or major depressive non treated syndromes
* Severe or non treated Eating Disorders implicated in obesity (compulsive access, bulimia)
* Patients under guardianship or with curators
* Women in age of procreation without means of effective contraception
* Pregnant or breast-feeding women
* Taking medicates such as: proteinate powder (Protifar ®, SP95 ®, Orlistat (Xenical ®, Ally ®), exenatide (Byetta ®), sitagliptin (Januvia ®, Xelevia ®), vildagliptin (Galvus ®), sitagliptin-metformin (Janumet ®), Vildagliptin-metformin (Eucreas ®), tadalafil (Cialis ®) sildenafil (Viagra ®)
* Drug addiction to opiates in the last six months
* Alcohol or drug abuse
* Infection by Human Immunodeficiency Virus (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
* Performed, in 2 to 3 days preceding the Dual-energy X-Ray Absorptiometry (DEXA) exam, of a bone scintigraphy or a digestive tract radiological examination with the use of barium type of contrast agent.

Primary outcomes:
measure: Total body fat mass
timeFrame: 6 months
Secondary outcomes:
measure: Weight
timeFrame: 6 months
Other outcomes:
Locations:
city: Rouen Cedex
country: France
facility: University Hospital of Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Vanessa FOLOPE, M.D.
role: PRINCIPAL_INVESTIGATOR
References: