ObesityEMFNCT01538654
Enteroprotein Modified Fast ( EMF )
An observational study of Obesity, run by M.D. Samir G. Sukkar at 1 site in Italy.
Trial summary
The purposes of the esperience is: 1. to verify the safety of protein sparing modified fast(PSMF) by enteral route ( EMF )performed in cycles of ten days/months for six months 2. to compare EMF with oral PSMF clinically ( appetite control, fat freemass mantainance, polmonary function tests and metabolic pattern) 3. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- enteral protein tube feeding in obese
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2011to 20 Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with BMI 30 - 45 Kg/m2
Who may be able to join
- 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
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- orthopedic diseases (coxarthrosis, gonarthrosis)
- hypertension
- non alcoholic hepatic steatosis
- accepting to be enrolled in the study (signing informed consent)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Genova, 16132
About this study
Official title: Enteroprotein Modified Fast ( EMF ) : Clinical Safety and Efficacy. A Six Months Pilot RCT
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
Read the detailed description
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.
- 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.
- Conditions
- Obesity
- Being tested
- enteral protein tube feeding in obese
- Keywords
- 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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral protein tube feeding in obeseProcedure or surgery
Also called EMF ( enteral modified fast )
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
| Study group | Role | What they receive |
|---|---|---|
| 'enteral protein tube feeding in obese | protein sparing modified fast with a defined enteral formula by tube Receives: Procedure: enteral protein tube feeding in obese |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSMF by tube feeding side effects
Evaluation of side effects due to enteral nutrition by tube with a PSMF in obese subjects
Measured: at the day 10th /month for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study start10 Mar 2011
- Primary completion20 Dec 2012
- Study completion20 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Samir G. Sukkar
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Foundation
- Responsible party
- Sponsor-investigator, M.D. Samir G. Sukkar, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Investigators
- Samir G Sukkar, MD, Study director, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538654
- Sponsor's protocol ID
- EMF2011
- Acronym
- EMF
- Status last verified
- Oct 2017
- First submitted
- 20 Feb 2012
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteroprotein Modified Fast ( EMF ) : Clinical Safety and Efficacy. A Six Months Pilot RCT
- ClinicalTrials.gov ID
- NCT01538654
- Acronym / sponsor ID
- EMF / EMF2011
- Conditions
- Obesity
- Keywords
- obesity, PSMF ( protein sparing modified fast), Enteral nutrition, Tube feeding, VLCD ( very low calorie diet), Pulmonary function tests, body composition, FFM ( fat free mass)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Samir G. SukkarUniversity, hospital or other
- Collaborators
- Nestlé Foundation
- Study start
- 10 Mar 2011 (actual)
- Primary completion
- 20 Dec 2012 (actual)
- Study completion
- 20 Dec 2012 (actual)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'enteral protein tube feeding in obese | – | Procedure: enteral protein tube feeding in obeseprotein sparing modified fast with a defined enteral formula by tube |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with BMI 30 - 45 Kg/m2
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral protein tube feeding in obeseAlso: EMF ( enteral modified fast )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 | Procedure or surgery | 'enteral protein tube feeding in obese |
Primary outcome
PSMF by tube feeding side effects
Time frame: at the day 10th /month for 6 months
Evaluation of side effects due to enteral nutrition by tube with a PSMF in obese subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir G Sukkar, MD study director
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by M.D. Samir G. Sukkar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSMF by tube feeding side effects (time frame: at the day 10th /month for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.