Enteroprotein Modified Fast ( EMF )

Study Overview
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Brief Summary
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The purposes of the esperience is: to verify the safety of protein sparing modified fast(PSMF) by enteral route ( EMF )performed in cycles of ten days/months for six months to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance, polmonary function tests and metabolic pattern) to verify the weight mantainance after 6 months from the treatment suspension

Detailed Description
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Rationale A) primary endpoint to verify the safety of protein sparing modified fast by enteral route ( EMF )in cycles of ten days/months repeated for six months, To compare EMF with oral PSMF clinically ( appetite control, polmonary function tests and metabolic pattern) and on metabolic parameters (hypertension, glucose intolerance, dyslipidaemia) maintaining body composition (particularly fat free mass and muscular strength) in 15 patients with disease-causing obesity not responding to medical treatment and/or cognitive/behavioural therapy, who are candidates for invasive treatment such as the gastric balloon or surgery but do not intend to undergo them compared with 15 undergoing the same regimen without the naso-gastric tube. To verify the effects of treatment with regard to the enteral-hormonal structure during the acute phase (selected sub-group) and while undergoing treatment. B) Secondary endpoints: To verify the percentage of patients who maintain the weight reached 6 months after stopping treatment with the naso-gastric tube associated with a high-calorie normal-protein diet. Verify clinical safety of EN in these patients.

Official Title
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Enteroprotein Modified Fast ( EMF ) : Clinical Safety and Efficacy. A Six Months Pilot RCT

Conditions
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Obesity

Intervention / Treatment
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* Procedure: enteral protein tube feeding in obese


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: both genders, outpatients aged between 16 and 75 with BMI 30 - 45 Kg/m2 that are not in a restricted diet since at least 3 months with obesity related comorbidities (- type 2 diabetes mild or moderate OSAS orthopedic diseases (coxarthrosis, gonarthrosis) hypertension non alcoholic hepatic steatosis accepting to be enrolled in the study (signing informed consent) Exclusion Criteria: Presence of gastrointestinal diseases Presence of cancer Patients treated with gastrolesive or anticoagulant drugs Hepatic failure, renal failure or multi-organ failure (cut off) Contraindications for enteral nutrition,Mechanical bowel complete, or partial chronic obstruction Severe mesenteric ischemia not caused by hypovolemia Digiunal or ileal fistula with high output (400 mL/die) Severe modifications of the intestinal function caused by enteropathies or insufficient absorbent surface, to the point that a normal nutritional state cannot be maintained Type 1 diabetes Type 2 diabetes treated with oral or injected drugs that may cause hypoglycemia ANBN: anorexia or bulimia nervosa, evaluation of other symptoms by specific tests Patients with major psychiatric disorders or not cooperative, or with alcohol or drug addiction disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 'enteral protein tube feeding in obese<br>protein sparing modified fast with a defined enteral formula by tube | Procedure: enteral protein tube feeding in obese<br>* The intervention is represented by a new alternative to treat obese patients by means of a protein sparing modified fast administered by continous 24 h enteral feeding<br>* Other names: EMF ( enteral modified fast );|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSMF by tube feeding side effects | Evaluation of side effects due to enteral nutrition by tube with a PSMF in obese subjects | at the day 10th /month for 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, PSMF ( protein sparing modified fast), Enteral nutrition, Tube feeding, VLCD ( very low calorie diet), Pulmonary function tests, body composition, FFM ( fat free mass), Body fat, Handgripstregth