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Nutritional Prognostic Factors in ALS (PEG-ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487536
Recruitment Status : Completed
First Posted : April 4, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Michele Barone, University of Bari

Study Description
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Brief Summary:

Background. Several nutritional factors have been evaluated as prognostic factors for survival in ALS patients at earlier stages of the disease [body mass index (BMI), body composition expressed as fat free mass (FFM), fat mass (FM), phase angle (PhA), low-density lipoprotein/high-density lipoprotein (LDL/HDL) ratio, cholesterol levels], while only two studies have evaluated some of these parameters after PEG placement.

Aim. BMI and cholesterol levels were evaluated as prognostic factors for survival after percutaneous endoscopic gastrostomy (PEG) placement Moreover, the relationship between body composition and BMI in a subgroup of ALS patients was evaluated.


Condition or disease Intervention/treatment
Nutritional Deficiency Neuro-Degenerative Disease Gastrostomy Other: Nutritional assessment

Detailed Description:
Methods. Nutritional and neurological parameters were assessed at the time of PEG placement (T0) in 47 consecutive patients. Body composition and PhA were measured in only 22 patients within 2 months from T0. Survival was calculated as the time from the PEG placement to tracheostomy or death.
Study Design
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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nutritional Prognostic Factors in Patients With Amyotrophic Lateral Sclerosis and Percutaneous Endoscopic Gastrostomy
Actual Study Start Date : January 2, 2006
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : July 31, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Nutritional assessment
    BMI and cholesterol levels evaluation

Outcome Measures
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Primary Outcome Measures :
  1. nutritional assessment [ Time Frame: at the time of PEG placement (one day) ]
    Weight and height (combined to report BMI in kg/m^2)

  2. biochemical nutritional assessment [ Time Frame: only at the time of PEG placement (one day) ]
    cholesterol levels


Secondary Outcome Measures :
  1. body composition assessment [ Time Frame: within 2 months from the PEG implantation (one day) ]
    Evaluation of fat mass and fat free mass


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study included 47 consecutive patients referring to the Neurological ALS Tertiary Centre, Department of Basic Medical Sciences, Neurosciences and Sense Organs, who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit, Department of Emergency and Organ Transplantation, of the same University Hospital. All patients fulfilled revised El Escorial criteria for probable or definite classical ALS.
Criteria

Inclusion Criteria:

  • ALS patients who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit

Exclusion Criteria:

  • ALS patients without PEG
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487536


Locations
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Italy
Policlinic Hospital
Bari, Italy, 70124
Sponsors and Collaborators
University of Bari
Investigators
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Principal Investigator: Michele Barone University of Bari
More Information
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Responsible Party: Michele Barone, Researcher, University of Bari
ClinicalTrials.gov Identifier: NCT03487536    
Other Study ID Numbers: Policlinic Hospital 2, Bari
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: the results have not yet been shared with all the authors

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurodegenerative Diseases
Malnutrition
Nutrition Disorders
Nervous System Diseases